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

Catalog Number	VCP322H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the device had a breakage needle.One empty opened box and twenty-two unopened samples of product code vcp322, lot jd7526 were returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected; also, the needles were examined under magnification and no defects, bending needle or needle breakage were found.The sutures were dispensed without problem and examined along of strand, no defects or damaged were observed.Besides, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that a patient underwent a perineal repair procedure on an unknown date and suture was used.During the procedure, the tip of the suture broke off.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VCL+ VIO 27IN 3-0 S/A MH
• 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: 8891139
• Report Number: 2210968-2019-85511
• Device Sequence Number: 11516012
• Product Code: GAM
• UDI-Device Identifier: 10705031052277
• UDI-Public: 10705031052277
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: 03/31/2020
• Device Catalogue Number: VCP322H
• Device Lot Number: JD7526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1