MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	L113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
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, the sutures were defective and broken.There was no patient involved in this event.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of fifty one devices.Visual inspection of the opened products returned noted two discolored and degraded sutures and two foil pouches with incomplete sealing mark in the vent hole.Visual inspection of the sealed products noted two discolored and degraded sutures with incomplete sealing marks.Functionally, the sealed samples were submitted to a haug bubble emission test and the two sutures with the incomplete sealing did not meet specifications.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The reported condition under was most likely caused by an error with the feeding and sealing station.The root cause of the observed condition was determined to be a result of a manufacturing activity.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, the sutures were defective and broken.There was no patient involved in this event.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8168916
• Report Number: 9612501-2018-02230
• Device Sequence Number: 11186709
• Product Code: GAM
• UDI-Device Identifier: 10884521045798
• UDI-Public: 10884521045798
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup
• Report Date (Section B): 08/28/2019

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: 01/31/2020
• Device Model Number: L113
• Device Catalogue Number: L113
• Device Lot Number: D5A0014X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 07/05/2019; 08/07/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 07/22/2019; 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1