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

Model Number	GM-322
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
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: occurred during a cesarean section procedure.The suture was being used to close the skin of the patient using the subcuticular closure.The needle separated from the thread during the closure.In order to resolve the issue and complete the case, they stopped suturing, removed the needle from the patient, and opened another pack of suture to finish the closure.There was no patient harm.The patient outcome is alive, no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the sample had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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: BIOSYN
• 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: 6990373
• Report Number: 9612501-2017-06516
• Device Sequence Number: 13760060
• Product Code: GAM
• UDI-Device Identifier: 20884521032696
• UDI-Public: 20884521032696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: 04/30/2022
• Device Model Number: GM-322
• Device Catalogue Number: GM-322
• Device Lot Number: D7D0745X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1