MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-36K DISP PUNCH 3.6MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN915269
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device".No report of patient harm or injury.The patient status is reported as "unknown".
Additional Manufacturer Narrative
Qn# (b)(4).Sample was received in its original packaging (sealed).No visual issues were observed.The punch was activated several times confirming that tip softly slides without getting stuck, testing conducted per procedure.A device history record review was performed, and no relevant findings were identified.Customer complaint cannot be confirmed as no quality issues were found during the evaluation of the representative sample.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device".No report of patient harm or injury.The patient status is reported as "unknown".

• Brand Name: PU DP-36K DISP PUNCH 3.6MM
• 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: 19028752
• Report Number: 3004365956-2024-00023
• Device Sequence Number: 12530005
• Product Code: DWS
• UDI-Device Identifier: 14026704697936
• UDI-Public: 14026704697936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Model Number: IPN915269
• Device Catalogue Number: DP-36K
• Device Lot Number: 74F2300380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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