MAUDE Adverse Event Report: TELEFLEX MEDICAL PU MDP-40K DISP PUNCH 4.0MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN056405

Device Problem Misfire (2532)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

We had two misfire in a case last week.

Manufacturer Narrative

Qn# (b)(4).Additional information: the tech that was in the case just got back to me as i'm not the one actually in the room for this.She said it is hard to say if an injury was caused but it caused the case to be extended because of the incident.The punch did not make a clear cut, it went through, got stuck and tore off making the hole bigger than desired.Also caused for more than normal suture repair.It has happened twice with two different doctors.

Event Description

We had two misfire in a case last week.

• Brand Name: PU MDP-40K DISP PUNCH 4.0MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11769589
• MDR Text Key: 251693277
• Report Number: 3004365956-2021-00174
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704714169
• UDI-Public: 14026704714169
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

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 Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: IPN056405
• Device Catalogue Number: MDP-40K
• Device Lot Number: 74G2002242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1