MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48

Model Number IPN000860

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

Reported issue: while using the sutures placement device, that it was impossible to properly recover the dart.The rescue wire was used to retrieve it.The consequence for the patient is an increase in the intervention time by a few minutes.This is an isolated incident.No reported injury.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.A device history review could not be conducted since the lot number and product code was not provided.No corrective action can be implemented due to the lack of product code and batch number to perform a proper investigation to determine a root cause.In conclusion, the customer complaint cannot be confirmed due to the lack of product sample and batch number to perform a proper investigation and determine a root cause.Teleflex will continue to monitor and trend related events.

• Brand Name: DEK BL MF 0 TC-43 2N 48
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16522172
• MDR Text Key: 311335873
• Report Number: 3004365956-2023-00016
• Device Sequence Number: 1
• Product Code: MFJ
• UDI-Device Identifier: 14026704603883
• UDI-Public: 14026704603883
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN000860
• Device Catalogue Number: 833-123
• Device Lot Number: 74K1800867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED