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

Model Number	VCP741D
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).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.(b)(4).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: could you please provide the lot number? event date? note: event reported in 2210968-2021-09132 and 2210968-2021-09133 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 cesarean section on an unknown date and suture was used.During the procedure, the suture was detached from the needle when passing the needle through the muscle layer.Another like device was used.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: VCL+ VIO 8X18IN 1 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: 12568204
• Report Number: 2210968-2021-09131
• Device Sequence Number: 3373375
• Product Code: GAM
• UDI-Device Identifier: 10705031055216
• UDI-Public: 10705031055216
• 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): 09/06/2021

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: VCP741D
• Device Catalogue Number: VCP741D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1