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

Model Number	SM-644
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
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, during a procedure, the needle was not connected to the thread when they opened the sterile package.Then after the operation, they opened several more that was in the same shape.They used the device as soon as they opened it up during the operation.The was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned products noted one suture and one needle.The needle was observed to be detached from the suture.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.The retainer was inspected with no abnormalities.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Unfortunately, because no sealed samples were received, a needle attachment test could not be performed.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: 7436327
• Report Number: 9612501-2018-00753
• Device Sequence Number: 1055473
• Product Code: GAM
• UDI-Device Identifier: 20884521033198
• UDI-Public: 20884521033198
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 05/31/2022
• Device Model Number: SM-644
• Device Catalogue Number: SM-644
• Device Lot Number: D7E0321X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1