MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-46-MG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the thread was broke very easily when knotted.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account and two sealed with the appropriate packaging.A visual inspection of the sealed samples noted no abnormalities.The visual inspection of the sample noted one suture and one needle.It was observed, under magnification, that the suture appeared to have split under tension.A tensile test was performed on the sealed samples and the results met the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7537272
• Report Number: 1219930-2018-02832
• Device Sequence Number: 1794370
• Product Code: GAM
• UDI-Device Identifier: 10884521045354
• UDI-Public: 10884521045354
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: GL-46-MG
• Device Catalogue Number: GL-46-MG
• Device Lot Number: B5E0163X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1