MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VASCUFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88864731-51V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open procedure, the 2 sutures have broken.The first thread was used when the surgeon begins to overjet and the needle was served in the middle of the overlock while the needle has loosened on the holder when using the second thread.The box was changed with another lot number to complete the case.There was no patient injury.

• Brand Name: VASCUFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8471453
• Report Number: 1219930-2019-01980
• Device Sequence Number: 1962996
• Product Code: GAT
• UDI-Device Identifier: 10884521102040
• UDI-Public: 10884521102040
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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 Expiration Date: 05/31/2023
• Device Model Number: 88864731-51V
• Device Catalogue Number: 88864731-51V
• Device Lot Number: A8E0529X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1