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

Catalog Number	VCP740D
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	11/04/2025
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 found hair-like foreign objects inside a package in the newly dispensed suture when it was opened to prepare for surgery.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) h 6.Investigation findings: c22 ¿ photo investigation.C22 photo investigation summary: according to the information received, it was reported foreign matter.It was reported that it was found hair-like foreign objects inside a package in the newly dispensed suture when it was opened to prepare for surgery.Changed another one to complete the surgery.There is no report on patient's injury.Enclosed please find defect photo.No additional information could be provided.The lot of ips is unavailable.This is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows an eight-wire winding former out of its packaging, with foreign matter inside sterile barrier in slot #8.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.H3 b01 investigation summary: the product was returned to ethicon for evaluation.One empty open foil packet and one winding former with eight undispensed strands were received for analysis.Product code vcp740d.Upon visual analysis of the sample, a foreign matter (appearing to be hair) was observed attached with adhesive tape on the winding former.Additionally, a paper lid was not returned.Given the current condition of the returned sample, it is not possible to definitively determine the root cause of the reported event.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Although no conclusion could be reached on the cause of the reported event.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 will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device and no non-conformances/manufacturing irregularities related to the malfunction were identified.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: VCL+ VIO 8X18IN 0 S/A CT-1 CR
• 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: 23691841
• Report Number: 2210968-2025-13347
• Device Sequence Number: 18735830
• Product Code: GAM
• UDI-Device Identifier: 10705031055193
• UDI-Public: (01)10705031055193(17)290531(10)101S2Q
• 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): 12/02/2025

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: VCP740D
• Device Lot Number: 101S2Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2024
• 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