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	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "suture flicked during surgery leaving the tiny bead at end of suture, leaving it inside patient while surgeon performing anterior repair.Surgeon ordered x-ray to ensure location of product inside patient".Additional information received states that "the 'dart' was seen on x-ray post op and is embedded in the patient.She has not been brought back into the theatre to remove it as they believe it would cause more damage".The patient's current condition is unknown.

• 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: 18940239
• Report Number: 3004365956-2024-00028
• Device Sequence Number: 6770134
• Product Code: GAT
• UDI-Device Identifier: 14026704735300
• UDI-Public: 14026704735300
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 833-224
• Device Lot Number: 74A2300905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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