MAUDE Adverse Event Report: ETHICON INC. VCL + BRD VIO 8X18IN USP3-0 S/A X-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP790D
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/24/2025.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 type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture?=>unk - are there any photos of the foreign matter available?=>unk - is it possible that the foreign material fell into packaging upon opening of device?=>unk - was the product seal on the foil still intact when the package was opened?=>unk - could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.=>the device has been received at (b)(6) and will be shipped.Please check rmao.Tracking number: (b)(4).- please provide the source or name of person providing answers to follow-up questions: (b)(6).H3 investigational summary: the product was returned to ethicon inc for evaluation.One winding former outside the foil packet was received for analysis.Product code vcp790d.During the evaluation of the returned sample, an unknown foreign matter (brown stain) was observed on the backside of the winding former.Additionally, the paper lid was removed, and no anomalies were detected in the needle-suture combinations.Based on the condition of the returned sample, it could not be determined what caused the event report.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During an unknown surgery, it was found that there had been a stain on the back of the package after the product was opened.This event was found before use.It was a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: VCL + BRD VIO 8X18IN USP3-0 S/A X-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: 22587448
• Report Number: 2210968-2025-08562
• Device Sequence Number: 21205518
• Product Code: GAM
• UDI-Device Identifier: 10705031055612
• UDI-Public: (01)10705031055612(17)290930(10)103XDB
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 07/24/2025

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: VCP790D
• Device Lot Number: 103XDB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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