MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP467H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Attempts have been 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.Additional information was requested and the following was obtained: did the needle tip fell into the patient? no.If so, was it retrieved during the same procedure? what was done to retrieve the broken tip? yes.If it wasn't retrieved.Size of the needle piece and tissue where it is being retained? are there any plans to remove it in the future? not clear.Needle found.It broke at the last knotting and it was retrieved could you please provide the lot number? rabbptw0.Procedure name? skin suture.Event date? (b)(6) 2021." trade name - irgacare "active ingredient(s) triclosan "dosage form suture/solid/parenteral "strength  = 275 g/m.
Event or Problem Description
It was reported that a patient underwent a skin suture procedure on (b)(6) 2021 and suture was used.During the procedure, the needle tip broke when placing the last skin stitch and the needle was retrieved.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: 08/09/2021.H6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 275 g/m.

• Brand Name: VCL+ VIO 27IN 0 S/A CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11957475
• Report Number: 2210968-2021-05344
• Device Sequence Number: 17244156
• Product Code: GAM
• UDI-Device Identifier: 10705031053496
• UDI-Public: 10705031053496
• Combination Product (Y/N): Y
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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 Expiration Date: 12/31/2023
• Device Model Number: VCP467H
• Device Catalogue Number: VCP467H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1