MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR26 2N 36" BSC; DEKLENE MAXX POLYPROPELENE NON

Catalog Number 833-235

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer complaint cannot be confirmed based only on the information provided, to perform a proper evaluation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the sample becomes available this investigation will be updated with the evaluation results.A device history record review was performed, and no relevant findings were identified.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "capio went into ssl the bullet stayed in the ligament and came off the suture.The bullet could not be palpated because it was deep in the ligament.Location was confirmed by intraoperative x-ray.".No patient harm or health consequences.The current status of the patient is reported as "no health consequences".

• Brand Name: DEK BL MF 0 TC-43/HR26 2N 36" BSC
• Type of Device: DEKLENE MAXX POLYPROPELENE NON
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18935640
• MDR Text Key: 338044379
• Report Number: 3004365956-2024-00013
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 14026704735324
• UDI-Public: 14026704735324
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 833-235
• Device Lot Number: 74C2202885
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED