MAUDE Adverse Event Report: TELEFLEX MEDICAL PU MDP-60K DISP PUNCH 6.0MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN917591

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

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.

Event Description

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

• Brand Name: PU MDP-60K DISP PUNCH 6.0MM
• 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: 15749071
• MDR Text Key: 307274869
• Report Number: 3004365956-2022-00088
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704735508
• UDI-Public: 14026704735508
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN917591
• Device Catalogue Number: MDP-60K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/07/2022
• 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