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

Model Number IPN917586

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

Event Description

It was reported that the customer has had multiple cases where the punches have been sticking.The patient's condition is unknown.

Manufacturer Narrative

Qn#: (b)(4).The device history review could not be conducted since the lot number was not provided.Teleflex will continue to monitor and trend related events.

• Brand Name: PU MDP-40K DISP PUNCH 4.0MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• 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: 15749084
• MDR Text Key: 303418571
• Report Number: 3004365956-2022-00094
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704735454
• UDI-Public: 14026704735454
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN917586
• Device Catalogue Number: MDP-40K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2022
• 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