MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A CT-3; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP327H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide procedure name and date? please explain in detail what was the issue with the device.What do you mean by ¿needle and suture was divided¿? did the needle pull off from the suture? did the needle broke? did the suture broke? when did the device present the alleged issue, before use on patient (pre-op), during use on patient (intra-op)or after use on patient (post-op).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 this is a combination product, and the event has been reviewed for both the suture and the triclosan.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, needle and suture became divided.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 3-0 S/A CT-3
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13285211
• Report Number: 2210968-2022-00482
• Device Sequence Number: 4944749
• Product Code: GAM
• UDI-Device Identifier: 10705031052314
• UDI-Public: 10705031052314
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 01/18/2022

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: 04/30/2026
• Device Model Number: VCP327H
• Device Catalogue Number: VCP327H
• Device Lot Number: REMCDX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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