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

Model Number	SM-823
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
According to the reporter, during a veterinary procedure it was noted that the sutures were weak and would break easily.Additional sutures from the same box were used to complete the case.Two days post operatively, the suture line broke and the veterinary patient had evisceration of intestine through abdominal wall.Veterinary patient chewed on their intestines, leading to 18 inches of bowel resection.Additional procedure was necessary to correct the issue.The veterinary patient expired five days after the original procedure.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of a device.The visual inspection and functional evaluation of the sample had acceptable results.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended 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: 7084801
• Report Number: 9612501-2017-06694
• Device Sequence Number: 1298002
• Product Code: GAM
• UDI-Device Identifier: 20884521033280
• UDI-Public: 20884521033280
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 06/30/2022
• Device Model Number: SM-823
• Device Catalogue Number: SM-823
• Device Lot Number: D7F2013X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention