MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP519H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
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.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.
Event or Problem Description
It was reported that a patient underwent a gynecological procedure on (b)(6) 2019 and suture was used.During the procedure, the suture pulled off the needle at the swage with minimal pull-force.The procedure was finished with like product.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Representative samples returned to support investigation of multiple device issues captured in reports 2210968-2019-82354, 2210968-2019-82355, 2210968-2019-82356, and 2210968-2019-82357.Analysis results have been included in follow-up reports for each.An opened box with ten unopened samples of product were returned for evaluation.The complaint sample was not received.During the visual inspection of ten unopened 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 suture was dispensed without problems and examined the strand with no defects, or damage observed.A functional test was performed and the pull force was 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 conditions of the samples received, no suture needle pull off was found, and the tested samples met the finished goods requirements.

• Brand Name: VCL+ VIO 36IN 1 S/A V-34
• 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: 8667528
• Report Number: 2210968-2019-82355
• Device Sequence Number: 14005088
• Product Code: GAM
• UDI-Device Identifier: 10705031054066
• UDI-Public: 10705031054066
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 07/31/2023
• Device Catalogue Number: VCP519H
• Device Lot Number: MJ7651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1