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

Model Number IPN915269

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2024

Event Type  malfunction  

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 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".

Manufacturer Narrative

(b)(4).One representative sample of catalog number dp-36k batch 74f2300380 was received for evaluation.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.The product ifu contain some warnings about the care and proper use of product.Like "remove the excised tissue before additional openings are created.Excessive cleaning of the punch in between cuts is not necessary.Failure to remove excised tissue from the punch or excessive cleaning may cause punch jamming or incomplete cuts." 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.

Event 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
• 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: 19027975
• MDR Text Key: 339224537
• Report Number: 3004365956-2024-00024
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697936
• UDI-Public: 14026704697936
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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