MAUDE Adverse Event Report: TELEFLEX MEDICAL TEV GN BR 0 TC-43/HR26 2N 36" BSC; TEVDEK II POLYESTER NON-ABSORB

Catalog Number	833-224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "theatre nurse reported an arrow head from a capio suture had broken off inside a patient.It was visualized on x-ray but it was unable to be removed.The case was successfully completed using another suture.Unfortunately, the capio device was disposed of.They attempted manual removal of the arrowhead unsuccessfully".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: TEV GN BR 0 TC-43/HR26 2N 36" BSC
• Common Device Name: TEVDEK II POLYESTER NON-ABSORB
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17642016
• Report Number: 3004365956-2023-00058
• Device Sequence Number: 8021928
• Product Code: GAT
• UDI-Device Identifier: 14026704735300
• UDI-Public: 14026704735300
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K192490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 833-224
• Device Lot Number: 74A2201901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown