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

Model Number	L-73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, the thread was broken into pieces in the package.The procedure was completed with another device.The patient status is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the open samples noted partial sutures and fragment of sutures with zero needles.There was a hole observed in one of the open samples.The visual inspection of one of the sealed samples noted a hole in the foil pouch.There was no hole in the breather pouch.The sample was opened by pmv.The visual analysis noted that this type of damage, hole on the corner of the pouch, is caused by compressing the pouch along its edges.It was concluded that there are no opportunities for the package to be compressed in a way that resembles the damage on the returned pouches.And since there are no records of any issues with the vision system during the packaging of this lot, the hole must have occurred after the unit left the manufacturing facility.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 hole in the foil pouch cannot be reliably determined considering vision systems are in place to prevent this issue and there is no indication that they were not functioning properly during the manufacturing of this lot.Improperly storing or handling the pouch can cause it to compress and damage the foil.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 LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6973634
• Report Number: 1219930-2017-08198
• Device Sequence Number: 10868557
• Product Code: GAM
• UDI-Device Identifier: 20884521046891
• UDI-Public: 20884521046891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K900122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 10/18/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1