MAUDE Adverse Event Report: ETHICON INC. VCL + CT BRD UD 8X18IN USP3-0 S/A SHB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPB864D
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
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 primary package of the suture was found damaged prior to use.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: 7/30/2025.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: please describe the sterile packaging, are there any tears/holes in the sterile packaging? please refer to the returned device.Were there any issues with the seal of the sterile packaging? yes.H3 investigational summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code vcpb864d.During the initial inspection of the sample, a tear was observed in the foil packet.This damage appears to has been caused from the outside in by an unidentified object, compromising the sterility of the package.Due to the damage found on the device, the complaint is confirmed.The condition of the package is indicative of handling and storage issues that occurred outside of ethicon control.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL + CT BRD UD 8X18IN USP3-0 S/A SHB 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: 22663862
• Report Number: 2210968-2025-08795
• Device Sequence Number: 7495923
• Product Code: GAM
• UDI-Device Identifier: 10705031056664
• UDI-Public: (01)10705031056664(17)290930(10)104DMC
• 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
• Report Date (Section B): 07/30/2025

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: VCPB864D
• Device Lot Number: 104DMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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