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

Catalog Number	D10084
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).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.The following information was requested, but unavailable: please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? unk - what was the texture? unk - please provide the lot number.Unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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, before using the product, it was found that there had been a foreign matter to the needle tip which was at the position marked ¿8¿.The needle tip also seems duller than usual.The product was in the sot tray.It was a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided from the hp.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/29/2026.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.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.H6 component code: c22 - photo analysis.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one paper lid and one winding former with seven needle suture combinations, one detached needle and one suture that pertains to product code d10084 were received for analysis.This product code is multistrand and should contains eight strands per packet.Upon visual analysis of the returned sample, the tip of the needle from slot # 8 was observed to have excess silicone, while the remaining needles showed no anomalies or foreign matter.The tip of the needles were examined and no anomalies were found during the evaluation.In addition, it was observed that the needle from slot #8 was detached from the suture.The needle was examined and the swage and attachment area were noted to be as expected; however the insertion mark could not be observed in the suture.Nine photographs were provided, depicting the following: three images of a winding former showing seven needle¿suture combinations, one detached needle, and one suture; three photographs with close-up views of the needle tips; one image showing foreign matter; another image containing measurements of that foreign matter; and a final photograph showing a label.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through eth quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: VCL+ VIO 8X18IN 1 S/A CTB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23851523
• Report Number: 2210968-2025-14377
• Device Sequence Number: 15852816
• Product Code: GAM
• UDI-Device Identifier: 10705031203198
• UDI-Public: 10705031203198
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: D10084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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