MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 2-0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP739D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
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.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: procedure name? no further information is available.Was the procedure completed successfully? how? no further information is available.No further information will be provided.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.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 ug/m.
Event or Problem Description
It was reported that a patient underwent a chest procedure on (b)(6) 2021 and suture was used.During the procedure, the needle was detached from the suture during interrupted suturing on the fascia.It was a control release needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 2-0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12576368
• Report Number: 2210968-2021-09197
• Device Sequence Number: 16988058
• Product Code: GAM
• UDI-Device Identifier: 10705031055179
• UDI-Public: 10705031055179
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/05/2021

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: 12/31/2025
• Device Model Number: VCP739D
• Device Catalogue Number: VCP739D
• Device Lot Number: RA2AJJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1