MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP493H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).The following information was requested, but unavailable: 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.H3 investigation summary: the product was returned to ethicon for evaluation.One detached needle outside is packaging was received for analysis.Product code: vcp493h.Upon visual inspection of the needle, 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and absorbable hemostat was used.The problem of the suture pulling off the needle happened in surgery.Changed to another one to complete the surgery additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b 5.Event description corrected b 5.Event description: it was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The problem of the suture pulling off the needle happened in surgery.Changed to another one to complete the surgery additional information was requested 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.
Event or Problem Description
Corrected b 5.Event description: it was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The problem of the suture pulling off the needle happened in surgery.Changed to another one to complete the surgery additional information was requested.

• Brand Name: VCL+ UD 18IN 5-0 S/A P-3 PRM MP
• 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: 23706961
• Report Number: 2210968-2025-13548
• Device Sequence Number: 10691228
• Product Code: GAM
• UDI-Device Identifier: 10705031053663
• UDI-Public: (01)10705031053663(17)291130(10)10577Z
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: VCP493H
• Device Lot Number: 10577Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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