MAUDE Adverse Event Report: ETHICON, LLC ETHICON; SUTURE, ABSORBABLE, NATURAL

Model Number	3813G
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
While closing, the surgeon found a tip of a needle on the drape.After consulting with the scrub tech, they found the needle that had the tip broken off (it was in the needle counter on the backtable).Needle tip attached to suture packet but this suture packet is unknown whether or not the lot number is the same.No injuries were occurred due to this and all staff in the room was aware of the occurrence.
Event or Problem Description
While closing, the surgeon found a tip of a needle on the drape.After consulting with the scrub tech, they found the needle that had the tip broken off (it was in the needle counter on the back table).Needle tip attached to suture packet but this suture packet is unknown whether or not the lot number is the same.No injuries were occurred due to this and all staff in the room was aware of the occurrence.

• Brand Name: ETHICON
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON, LLC; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6971148
• Report Number: 6971148
• Device Sequence Number: 10887170
• Product Code: GAL
• UDI-Device Identifier: 10705031004856
• UDI-Public: (01)10705031004856
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017
• Report Date (Section F): 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 3813G
• Device Catalogue Number: 3813G
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 10/31/2017
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 10/19/2017