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

Catalog Number MDP-60K

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported " [the user] used the punch on the artery of the patient and when it was released, the punch did not open as anticipated.As a result, the artery was torn." additionally it was reported that "an injury occured but not a death".The patient's current condition is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Event Description

It was reported " [the user] used the punch on the artery of the patient and when it was released, the punch did not open as anticipated.As a result, the artery was torn." additionally it was reported that "an injury occured but not a death".The patient's current condition is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Customer complaint is confirmed since the unit had the tip stuck and could not be disengaged manually.The core and blade were measured and all the measurements met the specification.Even though the unit was stuck there is not sufficient evidence to assure this is a manufacturing defect and it is unknown if instructions and warnings per the tifu were properly followed.No dimensional issues were found therefore it cannot be confirmed as a manufacturing defect.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19075874
• MDR Text Key: 339773836
• Report Number: 3004365956-2024-00036
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704698070
• UDI-Public: 14026704698070
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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 Catalogue Number: MDP-60K
• Device Lot Number: 74J2201587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1