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 Unspecified Tissue Injury (4559)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that they just did a kidney/pancreas transplant and the punch go stuck and it had to be cut out.The patient's condition is unknown.

Manufacturer Narrative

(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: 15749506
• MDR Text Key: 303220703
• Report Number: 3004365956-2022-00092
• 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?: Yes
• 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
• Patient Outcome(s): Required Intervention