MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 12X18IN 4-0 NON NDL; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP103G
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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.The following information was requested, but unavailable: please provide the procedure name and date.No further information is available.No further information will be provided.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 an unknown procedure on an unknown date and suture was used.During the procedure, the surgeon felt that the length of the suture was short by 10 cm when compared to a like product.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ VIO 12X18IN 4-0 NON NDL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11930401
• Report Number: 2210968-2021-05203
• Device Sequence Number: 14293610
• Product Code: GAM
• UDI-Device Identifier: 10705031051379
• UDI-Public: 10705031051379
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 09/30/2025
• Device Model Number: VCP103G
• Device Catalogue Number: VCP103G
• Device Lot Number: QLMBEH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1