MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 4-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP771D
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3 investigation summary: the product was returned to ethicon for evaluation.One opened box belonging to product code vcp771d was received for analysis.Upon visual inspection of the received box, it was noted that it contained eleven foil packets instead of the required twelve.Additionally, the foil packets were found to be relabeled.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Although no conclusion could be reached regarding the cause of the reported event, as part of ethicon's quality process, all devices are manufactured, inspected, and released to approved specifications.Further monitoring of complaint information will be performed for potential safety signals through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on 03/03/2025 and suture was used.Before use on the patient, incorrect quantity-missing packages.It was reported that there was one package of product less than expected when preparing for trauma surgery.There should be twelve package of products in the box, but actually there were only eleven package of products.Changed another one to complete the surgery.T upon visual inspection of the received box, it was noted that it contained eleven foil packets instead of the required twelve.Additionally, the foil packets were found to be relabeled.No additional information could be provided.There were no adverse consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 4-0 S/A SH-1 CR
• 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: 21894666
• Report Number: 2210968-2025-04435
• Device Sequence Number: 3442365
• Product Code: GAM
• UDI-Device Identifier: 10705031055452
• UDI-Public: (01)10705031055452(17)290731(10)102JKG
• 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): 04/23/2025

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: VCP771D
• Device Lot Number: 102JKG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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