MAUDE Adverse Event Report: ETHICON INC. VCL CT VIO 27IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J452H
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please clarify the event "sutures pulled out after procedure": cat presented with incisions that dehisced after a spay.One cat had to be taken to emergency care because its intestines were falling out of the opening.The suture ruptured and untied.Did the sutures rupture? yes.Did the suture knots untie? yes.Were there suture absorption issues? yes during our laboratory analysis.
Event or Problem Description
It was reported that a feline underwent a surgical procedure on 03/14/2018 and suture was used.Following the procedure, the ¿sutures pulled out¿.It was unknown how long after the procedure this occurred.Additional information was requested for clarification.
Additional Manufacturer Narrative
Investigation summary = >representative samples were returned for analysis.The representative samples were examined for visual defects.The packets were opened and during the visual inspection, the sutures were correctly placed on the winding former and the sutures were dispensed without problems and examined along of the strands and no defects or damaged were observed, the sutures did not present with defects.A functional test was performed and tensile force was above the minimum requirements.Per the condition of the representative sample, no defects were observed on the packet or the suture and the tested samples met the finished goods requirements.

• Brand Name: VCL CT VIO 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7511569
• Report Number: 2210968-2018-72780
• Device Sequence Number: 13897131
• Product Code: GAM
• UDI-Device Identifier: 10705031040014
• UDI-Public: 10705031040014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: 08/31/2022
• Device Catalogue Number: J452H
• Device Lot Number: LK8551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1