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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " capio suture material was defective during the surgical procedure for patient s.M.S.According to [ the user] , it broke at the end where it fits into the capio slim suture capture device.Therefore, it was necessary to open and use another thread to complete the procedure." additional infomation on the patient's statusis not avaible at this time.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.

• 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19212828
• Report Number: 3004365956-2024-00040
• Device Sequence Number: 15189034
• Product Code: GAT
• UDI-Device Identifier: 14026704735300
• UDI-Public: 14026704735300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Device Catalogue Number: 833-224
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown