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

Catalog Number	MDP-60K
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3004365956-2024-00036
• Device Sequence Number: 4720502
• Product Code: DWS
• UDI-Device Identifier: 14026704698070
• UDI-Public: 14026704698070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown