MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP345H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2025 and suture was used.During the procedure, when using suture to close the abdomen, the suture broke at one-third of the needle without pulling.Unable to use, urgently replenished during surgery to ensure smooth operation.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 component code: g07002 - device not returned this report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: - when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify --please refer to the event description, other information requested is unknown.- could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.--no device can be returned currently.

• Brand Name: VCL+ VIO 36IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21968711
• Report Number: 2210968-2025-04941
• Device Sequence Number: 12887524
• Product Code: GAM
• UDI-Device Identifier: 10705031077805
• UDI-Public: (01)10705031077805(17)290430(10)1019C5
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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 Catalogue Number: VCP345H
• Device Lot Number: 1019C5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female