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

Catalog Number	833-113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer complaint could not be confirmed due the product sample was not available to perform a proper investigation.Dhr investigation did not show issues related to complaint.Without the device to evaluate, the probable root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
"it was reported that during use on a patient, "there were times when the needle part and suture breaks".No patient harm or injury.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: TEV GN BR 0 TC-43 2N 48"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• 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: 18373668
• Report Number: 3004365956-2023-00078
• Device Sequence Number: 12657291
• Product Code: GAT
• UDI-Device Identifier: 14026704603869
• UDI-Public: 14026704603869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021019
• 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): 12/05/2023

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: 10/07/2025
• Device Catalogue Number: 833-113
• Device Lot Number: 74K2000848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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