MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number VCP311H

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 ug /.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, it was noted that the needle tip was blunt; this was accompanied by suture breakage.There were no patient consequences reported.

• Brand Name: VCL+ VIO 27IN 3-0 S/A SH-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON, INC. SAN LORENZO; road 183, km. 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13087259
• MDR Text Key: 282782520
• Report Number: 2210968-2021-12954
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031052192
• UDI-Public: 10705031052192
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K132580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VCP311H
• Device Catalogue Number: VCP311H
• Device Lot Number: RBBMHK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1