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

Model Number	J978H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Needle tip of ethicon coated vicryl undyed braided (polyglactin 910) synthetic absorbable suture lost during cesarean section.X-ray of abdomen and pelvis were negative for any radiopaque foreign body.The first stitch of 0 vicryl ctx was completed and then it was noted that the needle tip was broken off after the second stitch.It is unknown as to whether or not the first stitch had a broken needle tip.The remainder of the closure was continued after examining the surgical field and finding no evidence of the needle tip.The uterus was closed with a running unlocked suture.It was then imbricated with 0 monocryl in a horizontal imbricating suture and the bladder flap was closed after hemostasis was assured using 2-0 pds in a running unlocked suture.The field was again examined and no needle tip was encountered.Hemostasis was assured on the hysterotomy and the peritoneum was closed using 3-0 vicryl in a running unlocked suture.At this point, x-ray was called and multiple x-rays were taken of the patient's abdomen.There were no needle tips noted on the x-rays per the radiologist.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; route 22 west p.o. box 151; somerville NJ 08876
• MDR Report Key: 11982537
• Report Number: 11982537
• Device Sequence Number: 3304528
• Product Code: GAM
• UDI-Device Identifier: 10705031043800
• UDI-Public: (01)10705031043800
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021
• Report Date (Section F): 06/03/2021

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: J978H
• Device Catalogue Number: J978H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 96
• Date Report Sent to FDA: 06/03/2021