MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A MH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP323H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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: procedure name and date? not provided.Was there any change in blood pressure? not provided what amount of blood loss (mls) occurred?not provided patient weight? (for pediatric complaints of blood loss) not provided.How was the bleeding controlled? not provided.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? not provided.Was medical/surgical intervention performed? not provided.Please provide the lot number? not provided.Was there a surgical delay? not provided.Trade name - irgacare®, active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/pa,renteral, strength ¿ = 275 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2021 and suture was used.During the procedure, while suturing was in progress, the needle broke.The broken portion of needle was removed from tissue and discarded.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 2-0 S/A MH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13089692
• Report Number: 2210968-2021-12981
• Device Sequence Number: 5319956
• Product Code: GAM
• UDI-Device Identifier: 10705031052291
• UDI-Public: 10705031052291
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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 Model Number: VCP323H
• Device Catalogue Number: VCP323H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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