MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP345H
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2026, and suture was used.It was reported that there was one package of product less than expected in the box during normal checking.Not involved in any surgery.There should be thirty-six packages of products in the box, but actually there were only thirty-five packages of products.There is no report on patient's injury.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/28/2026.B3: exact date is unk.Assumed first day of the month.Investigation summary the product was returned for evaluation.One opened box belonging to product code vcp345h was received for analysis.To complement this analysis, one photo was provided; and showed two open boxes one box pertain to the product code vcp345h, while the other box pertains to the product code vcp310h.Upon visual inspection of the received box, it was noted that it contained thirty-five foil packets instead of the required thirty-six.Additionally, the box was received completely open, and the tab dispenser was removed from the box.However, it could not be determined whether only thirty-five samples were originally placed inside the box.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.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.

• Brand Name: COATED VICRYL
• 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: 25016323
• Report Number: 2210968-2026-04562
• Device Sequence Number: 13337871
• Product Code: GAM
• UDI-Device Identifier: 10705031077805
• UDI-Public: (01)10705031077805(17)300831(10)10AT03(21)
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 10AT03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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