MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 3-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP344H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mh2826 number, 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 the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: it was received for analysis a top foil, an empty labeled winding former and a detached needle of product code vcp344, lot mh2826.During the visual inspection of the needle, the swage and attachment area were noted to be as expected.No suture remnant was observed into the barrel hole and the suture was not received to determine the assignable cause.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the suture was not received, it could not be determined what may have caused the reported incident.

• Brand Name: VCL+ VIO 36IN 3-0 S/A CT-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: 8848502
• Report Number: 2210968-2019-84959
• Device Sequence Number: 2471536
• Product Code: GAM
• UDI-Device Identifier: 10705031052536
• UDI-Public: 10705031052536
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/05/2019

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: 06/30/2023
• Device Catalogue Number: VCP344H
• Device Lot Number: MH2826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/19/2019
• Patient Sequence Number: 1