MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR 26 2N; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000861
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	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Suture was being retracted from patient to re-throw and bullet was missing upon extraction.

• Brand Name: DEK BL MF 0 TC-43/HR 26 2N
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11685790
• Report Number: 3004365956-2021-00136
• Device Sequence Number: 11487859
• Product Code: GAW
• UDI-Device Identifier: 14026704603890
• UDI-Public: 14026704603890
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K930738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: Health Professional
• Device Model Number: IPN000861
• Device Catalogue Number: 833-124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1