MAUDE Adverse Event Report: COVIDIEN LP V-LOC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VLOCN0326
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure a 0 vloc needle popped off the suture with no real resistance.2 sutures from the same lot # had the same problem.

• Brand Name: V-LOC
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12656094
• Report Number: 12656094
• Device Sequence Number: 1309359
• Product Code: GAT
• UDI-Device Identifier: 20884521127880
• UDI-Public: (01)20884521127880
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/29/2021
• Report Date (Section F): 09/29/2021

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: No Information
• Device Model Number: VLOCN0326
• Device Lot Number: A9H1079VY & AOF1088VY
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/29/2021