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Quality Failures

Withholding & Withdrawing due to quality defects in Medical Devices -  2016
Product Name Brand Name Batch No / Lot No Manufacturer Local Agent Failure/Defect Decision
Double Blood Bags Compoflex 851D03AA00 Fresenius Kabi – China For Fresenius Kabi - Germany Premium International (Pvt) Ltd Presence of white patches inside the blood bags Withdraw the batch on 06.01.2016
Disposable Syringe With Needle 3ml (23 G 31mm) N/A 20150515 Jiangsu Kangyou Medical Instrument Co Ltd - China Diagnomed  International (Pvt) Ltd Samples are unsatisfactory due to presence of foreign particles in the barrel and on the  plunger of syringe in sealed packs. Withdraw the batch on 16.02.2016
Auto  Disable Syringe With Needle 0.5ml (23 G 25mm) N/A 1406005 Wuxi Yushou Medical Appliance Co Ltd - China Diagnomed  International (Pvt) Ltd Samples are unsatisfactory as the rubber pistons in most of syringes were melted in intact packs Withdraw the batch on 08.03.2016
Esophageal Ligator Band N/A 615 – 622 -200/15-16 Shaili Endoscopy – India Kish International (Pvt) Ltd Substandard quality & high risk withhold the product on 21.03.2016
Four lumen catheter set for catheterization for vena cava Certofix Quattro Article Nos : 4167775S, 4167767, 4167775, 4167783, 4163443, 4168894, 4163492, 4168208, 4167784S,4168178, 4167772S, 4163443, 4164038, 4169960, 4169972 B.Braun Melsungen Ag - Germany B.Braun Lanka (Pvt) Ltd A leakage was observed during the internal quality checks by the manufacturer Decision taken to dispose the defective stocks on 08.04.16 (as per the urgent field safety notice issued by the manufcaturer)
Closed System Colostomy Bag Angeltouch Colobag 1361 J and 1306 L Angiplast Private Limited - India A.J.Medichem International (Pvt) Ltd Poor adhesiveness, Leakage & Irritation while using it Withheld the batches on 05.05.2016
Quadruple Blood Bags Compoflex 85IG14AA00 Fresenius Kabi  (Guangzhou) Co Ltd– China For Fresenius Kabi - Germany Premium International (Pvt) Ltd Rupture of bags while centrifuge, and Leakage of fluid from a bag. Withdraw the batch on 01.06.2016
Absorbent Cotton Wool S.L.S Tas- Med 666 Tas Medical Suppliers & Co(Pvt) Ltd, Piliyandala. Tas Medical Suppliers & Co(Pvt) Ltd Sample is unsatisfactory due to colour of the wrapping (Green) was adsorbed to the surface of thecotton wool roll. Withheld the batch on 09.07.2016
Intravenous Infusion Sets Euro Med Not applicable Jimit Medico Surgicals – India Pharma Associates Poor regulators, air leakage, pores in the chamber have led to saline leak, blockage of thelumen, infusion set not fixed to irrigation channel of the irrigation catheter, “Y” site causes infection, an insect found at the needle point and black hair like structure in the drip chamber.
Withdraw the product on 15.07.2016
Esophageal Metal Stent(covered length 100mm,stent diameter 120mm, wire diameter 0.20mm) N/A 444-448-35/15-16 C Shaili Endoscopy - India Poor quality (Complaint received from several End users) Withdraw the batch on 27.07.2016
Disposable Syringe 20ml Yile 20130505 Jiangsu  Yile  Medical  Article Co Ltd - China Lloyds Automart (Pvt) Ltd Samples are unsatisfactory due to leakage through the plunger Withheld the batch on 09.08.2016
Absorbent Surgical Gauze  100 m(Not sterilized ) N/A MLRT 001/0004/2015 Sisira Industries - Batapola Sisira Industries - Batapola Sample does not confirm to BP specification with respect to labeling.(Type of the gauze isnot mentioned on the label) Withheld the batch on 10.08.2016
Poly (Glycolide Co L Lactide) Dyed Braided Coated Suture with Needle NOVOSYN 116051 B.Braun Surgical SA - Spain B.Braun Lanka (Pvt) Ltd Incorrect suture was packed Withdraw the batch on 06.09.2016 (as per the urgent field safety notice issued by the manufcaturer)
Polyglycolic Acid Coated Braided Synthetic Absorbable Surgical Suture USP 4-0 (Metric 1.5) 75cm I -Col L11-033N Stericat Gutstring (P) Ltd - India Akbar Pharmaceuticals Pvt Ltd Sample is unsatisfactory due to needle is broken into pieces in some intact packs Withheld the batch on 19.09.2016
Monofilament Polyamide Non Absorbable Surgical Suture USP 2 (Metric 5) 75cm Sterilon H14-080Q Stericat Gutstring (P) Ltd - India Akbar Pharmaceuticals Pvt Ltd Sample is unsatisfactory due to needle was detached from the suture in some intact packs Withheld the batch on 19.09.2016
Elastic Adhesive Bandage BP (1993) 10cm x 4.5m (Stretched)(Zinc Oxide Elastic Adhesive Bandage) Sunlight SLEAB160402 Anji Sunlight Medical Products Co Ltd - China Medisurg International Sample does not confirm to BP (1993) specifications with respect to the test for “ content of Zinc Oxidein the adhesive mass” Withdraw the batch on 18.10.2016
Disposable Syringe 10ml (0.8 G x 38mm) Dispovan 542103EJG1 Hindustan Syringes & Medical Devices Ltd - India Citihealth Imports Pvt Ltd Samples are unsatisfactory due to test for absorbance does not confirm to BP specification and foreignparticles were observed in sealed packs Withdraw the batch on 31.10.2016
Balloon Catheter – 2Way Paediatric    Size : 10CH/FR Urocare 14-G-01D and 13-G-18D Uro Technology SDN BHD - Malaysia Akbar Pharmaceuticals Pvt Ltd Sample is considered unsatisfactory due to presence of white/black substances on & inside thecatheters in intact pouches which was identified as microbial contamination. Withdraw the batches on 31.10.2016
Polypropylene Suture 8/0  8mm 3/8c Round body double arm Premilene 114395 B.Braun Surgical SA - Spain B.Braun Lanka (Pvt) Ltd The needle is thicker and gives rise to post- operative bleeding. Withheld the batch on 04.11.2016
Elastic Adhesive Bandage BP (1993) 7.5cm x 4.5m (Stretched)(Zinc Oxide Elastic Adhesive Bandage) Sunlight SLEAB160401 Anji Sunlight Medical Products Co Ltd - China Medisurg International Sample does not confirm to BP (1993) specifications with respect to the test for “ content of Zinc Oxidein the adhesive mass” Withdraw the batch on 16.12.2016
Measured Volume Fluid Administration Set 150ml Vitromed VB16084 Vitromed Healthcare - India Shield Medical (Pvt) Ltd Sample is considered unsatisfactory due to the observation of a foreign particle inside theburette  chamber of the administration set (Opened pack) Withdraw the batch on 26.12.2016
Peracetic Acid 0.35%W/V Saniscope Not applicable Sirmaxo Chemicals Pvt Ltd - India Citihealth Imports Pvt Ltd Poor solubility Withdraw the product on 27.12.2016
Withholding & Withdrawing due to quality defects in Medical Devices - November 2015
Product Name Brand Name Batch No / Lot No Manufacturer Local Agent Failure/Defect Decision
Disposable Syringe With Needle - 5ml N/A 20140630 Shandong Weigao Group Medical Polymer Co Ltd - China Shield Medical (Pvt) Ltd - Battaramulla Batch Withheld on 12.05.15
Disposable Syringe With Needle - 3ml N/A 141022 Changzhou Medical Appliance General Factory Co Ltd - China MG Medicals (Pvt) Ltd Batch Withdrawn on 28.05.15

Summary Reports for Poor Quality Device  – Year 2010 to 2011

Product Name Brand Name LotNo/ Batch No Manufacturer Local Agent Decision taken by MDESC/ TAC/
Recall Commi
ttee
Disposable Syringe with Needle 10ml NA 20100822
Anhui Tiankang Medical Prodsucts Co Ltd - China Diagnomed International Product Withdrawal on 15.07.2011
Absorbable Synthetic Suture Ecosorb C9118 B9204
E9255
Vigilenz Medical Devices Sdn Bhd - Malaysia Shield Medical (Pvt) Ltd Batches Withdrawal on 02.04.2011
Disposable Infusion Set 20drops/ml NA 20100728
2010112
Jiangsu Kangyou Medical Instrument Co Ltd - china Diagnomed International Batch Withdrawal on 25.03.2011&09.05.2011

Non Absorbable
Monofilament
Nylon/Polyamide

Sinormed 100310 Shandong Sinormed Co Ltd - China Diagnomed International Batch Withdrawal on 02.04.2011
Non Absorbable
Monofilament Polyamide
Needle Sutures
Brilon J0042 Devices Sdn Bhd -
Malaysia Vigilenz
Medical
Shield Medical (Pvt) Ltd Batch Withdrawal on 30.03.2011
Synthetic Absorbable Poly Glycolic Acid Coated/Uncoated Braided Needle Suture BP/USP I - COL B9-061
J8-008
18-065
K8-052
Stericat Gustrings (Pvt) Ltd Akbar Pharmaceuticals (Pvt) Ltd Batches Withdrawal on 31.03.2011
Disposable Syringe PROTOS 08093 Shandong Protos  Medical Products Co Ltd - China Dowell International (Pvt0 Ltd Batch Withdrawal on 09.05.2011
IV Catheter with Wings
& Port with additional luer cap
NA 07J28616 Benchmark Technologies Pvt Ltd - India Sisili Projects Consortium (Pvt) Ltd Batch Withdrawal on
09.05.2011
Disposable Stomach Tube 18G ANGELTOUCH - Angiplast Pvt Ltd - India AJ Medichem international (Pvt) Ltd Discontinue use of packs which show the defect
Disposable Insulin Syringe with Needle 1ml HOPE 20101109
20110610
Jiangxihengte Industry Co Ltd - China Sri Chin Holdings Batch Withdrawal on
30.07.2011 &05.12.2011
Disposable Syringe with Needle 5ml NA 20100626 Jiangsu Kangyou Medical Instrument Co Ltd - China Diagnomed International Batch Withdrawal on 28.07.2011
Disposable Syringe with Needle 3ml
NA 20100719 Jiangsu Kangyou Medical Instrument Co Ltd - China Diagnomed International Batch Withdrawal on 28.07.2011
Disposable Syringe with Needle 10ml NA 20110418 Jiangsu Kangyou Medical Instrument Co Ltd - China Diagnomed International Batch Withdrawal on 12.12.2011
Disposable Syringe 50ml PENTA 10D01 Penta Ferte - Italy Leader Pharma Agency Batch Withdrawal on 29.07.2011
Disposable Syringe 1ml Lifecare 20101015 Not indicated NA(Have not been registered in CDDA) Batch Withdrawal on 22.07.2011
Surgical Absorbent Gauze 36” x 100m NA NA Mallika Industries – Sri Lanka Mallika Industries Product Withdrawal on 29.09.2011
I.V.Infusion Set 20Drops/ml PROTOS BT 11-034 Shandong Protos  Medical Products Co Ltd - China Dowell International (Pvt) Ltd Dowell International (Pvt) Ltd
Cholesterol – HDL (PTA) Reagent NA 031024C Biolabo SA- France Analytical Instrument (Pvt) Ltd Batch Withhold on 24.11.2011
Examination Gloves NUGARD 1414620
1416520
1416420
Terang Nusa Sdn Bhd - Malaysia Shield Medical (Pvt) Ltd Batches Withdrawal on 16.11.2011

 

Withholding & Withdrawing due to quality defects in Medical Devices - November 2015
Product Name Brand Name Batch No / Lot No Manufacturer Local Agent Failure/Defect Decision
Disposable Syringe With Needle - 5ml N/A 20140630 Shandong Weigao Group Medical Polymer Co Ltd - China Shield Medical (Pvt) Ltd - Battaramulla Batch Withheld on 12.05.15
Disposable Syringe With Needle - 3ml N/A 141022 Changzhou Medical Appliance General Factory Co Ltd - China MG Medicals (Pvt) Ltd Batch Withdrawn on 28.05.15