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

Model Number	J269H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, tiny tip of needle broke off.Ct and xray done.No foreign body was found.Md disclosed to the patient.No patient harm.

• 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: 7876239
• Report Number: 7876239
• Device Sequence Number: 13972278
• Product Code: GAM
• UDI-Device Identifier: 10705031038431
• UDI-Public: (01)10705031038431
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/04/2018
• Report Date (Section F): 09/11/2018

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: No Information
• Device Model Number: J269H
• Device Catalogue Number: J269H
• Device Lot Number: MBK708
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/11/2018