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

Model Number	IPN000860
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Report Number: 3004365956-2023-00016
• Device Sequence Number: 2351750
• Product Code: MFJ
• UDI-Device Identifier: 14026704603883
• UDI-Public: 14026704603883
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN000860
• Device Catalogue Number: 833-123
• Device Lot Number: 74K1800867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/10/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown