MAUDE Adverse Event Report: TELEFLEX MEDICAL BON GN BR 0 TC-43 2N 48"; SUTURE, ABSORBABLE

Model Number	IPN000866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.The device history review could not be conducted since the lot number was not provided.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the customer loaded bondek suture onto device the bullet broke off suture.Bullet stayed stuck in bottom of device.

• Brand Name: BON GN BR 0 TC-43 2N 48"
• Common Device Name: SUTURE, ABSORBABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11379384
• Report Number: 3004365956-2021-00059
• Device Sequence Number: 14452160
• Product Code: GAM
• UDI-Device Identifier: 04026704603930
• UDI-Public: 04026704603930
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K991191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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: IPN000866
• Device Catalogue Number: 833-213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1