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

Catalog Number	VCP771Z
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	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: craniotomy hematoma removal surgery.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.1.Please describe the type of foreign matter that was observed 2.What was the foreign matter¿s appearance? 3.What was the texture? 4.Are there any photos of the foreign matter available? -- photo.6.Was the product seal on the foil still intact when the package was opened? --yes.The photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.No product is available for return.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances 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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.The nurse prepared preoperative items and found a yellow foreign object inside the newly opened suture.It was discarded and replaced with a new suture, and the above situation did not occur again.Additional information has been 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: 25521785
• Report Number: 2210968-2026-06390
• Device Sequence Number: 21472153
• Product Code: GAM
• UDI-Device Identifier: 10705031055452
• UDI-Public: (01)10705031055452(17)291231(10)1065KZ
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: VCP771Z
• Device Lot Number: 1065KZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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