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

Model Number	L-73
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when the user attempted to use the product during the procedure, the thread was deteriorated and it could not be used.The procedure was completed with another device.The event occurred during the procedure but the product was not used for the patient.The status of the patient is alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Investigation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned products noted suture fragments.The foil pouch was inspected and found to have a hole.The suture degradation was due to the hole in the foil pouch.Samples were sent to engineering for further evaluation of hole in foil pouch.Engineer concluded that during processing, there are no opportunities to create this type of hole between the foil inspection and placement into the breather pouch.In addition, the hole in the pouch does not appear to be a single pierce but rather resembles a tear or rip.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The root cause of the suture degradation was due to a hole in the foil pouch.However, the root cause of the hole in the foil pouch cannot be reliably determined.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.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 NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6761109
• Report Number: 1219930-2017-06138
• Device Sequence Number: 878173
• Product Code: GAM
• UDI-Device Identifier: 10884521046894
• UDI-Public: 10884521046894
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2018

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: 08/31/2019
• Device Model Number: L-73
• Device Catalogue Number: L-73
• Device Lot Number: A4H0873X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 01/19/2018; 02/16/2018
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 02/06/2018; 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1