MAUDE Adverse Event Report: ETHICON VICRYL; SUTURE

Model Number V449G S33

Device Problems Break (1069); Detachment Of Device Component (1104); Out-Of-Box Failure (2311); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2017

Event Type  No Answer Provided  

Event Description

The suture out of this box seems to be defective.The needle keeps breaking of the suture with normal handling.The needle broke off both arms within 2-4 passes of the suture.

• Brand Name: VICRYL
• Type of Device: SUTURE
• Manufacturer (Section D): ETHICON; blue ash OH 45242
• MDR Report Key: 6383855
• MDR Text Key: 69488137
• Report Number: MW5068308
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 30705031051267
• UDI-Public: (01)30705031051267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: V449G S33
• Device Catalogue Number: V449G
• Device Lot Number: KD6190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1