MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A UR-5; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP376H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Evaluation: unopened samples of product were returned for analysis.The complaint sample was not received.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strands with no defects or suture breakage observed.A functional test was performed using and the pull force and tensile force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no suture needle pull off or suture breakage was found, and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and the suture was used.It was reported that during surgery, the suture was behaving like a de-tach suture, meaning the suture was coming away from the swage.There were no adverse patient consequences reported.

• Brand Name: VCL+ VIO 27IN 0 S/A UR-5
• 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: 9100709
• Report Number: 2210968-2019-87957
• Device Sequence Number: 14119447
• Product Code: GAM
• UDI-Device Identifier: 10705031052895
• UDI-Public: 10705031052895
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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: 07/31/2021
• Device Catalogue Number: VCP376H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/20/2019
• Patient Sequence Number: 1