MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J532H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot pdz556, and no non-conformances were identified.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 lateral incision and suture of perineum procedure on 10/11/2020; and suture was used.During the procedure, the suture pulled off the needle while sewing the muscle layer.The needle was located by ultrasound and retrieved.There were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10748742
• Report Number: 2210968-2020-08403
• Device Sequence Number: 3899345
• Product Code: GAM
• UDI-Device Identifier: 10705031040984
• UDI-Public: 10705031040984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• 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
• Report Date (Section B): 10/20/2020

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: 03/31/2024
• Device Model Number: J532H
• Device Catalogue Number: J532H
• Device Lot Number: PDZ556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR