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

Model Number	IPN056405
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
We had two misfire in a case last week.
Event or Problem Description
We had two misfire in a case last week.
Additional Manufacturer Narrative
(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.

• Brand Name: PU MDP-40K DISP PUNCH 4.0MM
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11769609
• Report Number: 3004365956-2021-00173
• Device Sequence Number: 3104681
• Product Code: DWS
• UDI-Device Identifier: 14026704714169
• UDI-Public: 14026704714169
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1