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

Model Number	88864705-01V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 vessel suturing  in an open procedure, when the surgeon was tying the thread, the needle detached from the thread and disappeared.It was noted that the needle did not fell into the patient cavity but it was never found.To resolve the issue, a new suture was used.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: 12413757
• Report Number: 1219930-2021-03626
• Device Sequence Number: 3515977
• Product Code: GAT
• UDI-Device Identifier: 10884521101852
• UDI-Public: 10884521101852
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 88864705-01V
• Device Catalogue Number: 88864705-01V
• Device Lot Number: A8E0398X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1