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

Model Number 3813G

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/18/2017

Event Type  malfunction  

Event 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 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
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON, LLC; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6971148
• MDR Text Key: 90041537
• Report Number: 6971148
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031004856
• UDI-Public: (01)10705031004856
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

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