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

Model Number	CM-966
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2017
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, during cesarean section procedure, the device needle was broken and needle tip was fell into patient's cavity.There was no stated information how the needle tip was retrieved.No patient injury has been noted.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted 1 suture and 1 needle.A tactile and microscopic examination of the sutures revealed no signs of material or assembly process damage.The needle was received broken at the tip.Upon microscopic inspection of the needle, instrument marks were observed at the break site of the needle body.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 observed damage was misuse of the product which would have caused or contributed to the reported incident.The observed instrumentation damages suggested that the needles were grasped improperly at the needle tip during application.Firmly grasping the needle at the tip weakens the needle causing it to bend and/or break.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.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: 7161745
• Report Number: 9612501-2018-00014
• Device Sequence Number: 18856058
• Product Code: GAM
• UDI-Device Identifier: 10884521032279
• UDI-Public: 10884521032279
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: 01/31/2022
• Device Model Number: CM-966
• Device Catalogue Number: CM-966
• Device Lot Number: D7A1706X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1