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

Catalog Number	VCPB945H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
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.It was reported that the problem of pulling off suture needle happened in surgery.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/1/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested.The following was obtained: if it becomes available in the future, please provide lot number.The lot number is 102krr.When did the needle detach/pull off from the suture thread (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? please refer to the event description, other information requested is unknown.H3.Investigational summary: the product was returned to ethicon for evaluation.One detached needle and one suture outside its packaging were received for analysis.Product code vcpb945h.Upon visual inspection of the needles, an incorrect swage was noted since the mark of the swage area was higher than usual (near the solid part of the needle) and consequently, caused a pull-off.Based on the information currently available, an incorrect swage was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL+ UD 36IN 2-0 S/A CTB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23682252
• Report Number: 2210968-2025-13322
• Device Sequence Number: 9807996
• Product Code: GAM
• UDI-Device Identifier: 10705031056701
• UDI-Public: (01)10705031056701(17)290731(10)102KRR
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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: VCPB945H
• Device Lot Number: 102KRR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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 Sex: Unknown