MAUDE Adverse Event Report: ETHICON, LLC COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number J258H

Device Problem Dull, Blunt (2407)

Patient Problem Skin Tears (2516)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

The nurse midwife was repairing a vaginal tear after delivery and had made two swipes through and noticed that something did not feel right.Upon examining the suture needle, she noticed that the tip was blunt and not intact.Got another suture needle completed the repair.Felt all around the area did not feel any sharp object.Performed an x-ray, no object was identified.Needle saved along with the packaging.3-0 vicryl ct-1 taper needle.

• Brand Name: COATED VICRYL
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; route 22 west, p.o. box 151; somerville NJ 08876
• MDR Report Key: 8909885
• MDR Text Key: 154866006
• Report Number: 8909885
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031038295
• UDI-Public: (01)10705031038295
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2019

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: Other
• Device Model Number: J258H
• Device Catalogue Number: J258H
• Device Lot Number: MPM718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Weight: 90