MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 4-0 S/A PC-5 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP823H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/17/2025.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.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: (b)(4): px: hmb, qty: 1, code: vcp823h; lot #: 1043kh.(b)(4): px: mks, qty: 3, code: vcp823h; lot #: 1043kh.(b)(4): px: so, qty: 1, code: vcp823h; lot #: 1043kh.(b)(4): px: mv, qty: 2, code: vcp823h; lot #: 1043kh.(b)(4): px: bj, qty: 1, code: vcp823h; lot #: 1043kh.- did the reported issue contribute to any patient adverse consequences? none - is the product available for return? if yes, please document timeline of shipment to the office.If the product is no longer available for return, please state so in your response.Yes.It will be send to j&j office by friday (b)(4) 2025 - please provide the source or name of person providing answers to follow-up questions: (b)(4) or head or dept.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.The single complaint was reported with multiple events.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.It was reported that the thread was detaches from the needle during suturing.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 11/5/2025.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.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.One empty labeled winding former, one detached needle and a suture piece were received for analysis.Product code vcp823h.During the visual inspection of the detached needle, the swage area and the edge were noted with marks probably caused by a surgical instrument.This condition likely caused the needle to detach from the suture.Additionally, remnants of the suture were observed in the needle hole.The suture received was inspected, and the extremes were noted to be cut probably caused by a surgical instrument.Furthermore, body fluids were also observed on the strand.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL+ UD 18IN 4-0 S/A PC-5 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: 23075497
• Report Number: 2210968-2025-10579
• Device Sequence Number: 9719919
• Product Code: GAM
• UDI-Device Identifier: 10705031055674
• UDI-Public: (01)10705031055674(17)290930(10)1043KH
• Combination Product (Y/N): Y
• Initial Reporter Country: RP
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: VCP823H
• Device Lot Number: 1043KH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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