MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN920986
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when covering the punch, a green colored particle (the color of the cap) was found stuck to the beginning of the punch, which was going to be inserted into the aorta.So there was a risk of migration into the bloodstream.The utensil was wiped with a damp compress.The particle was set aside".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer's complaint cannot be confirmed because a visual and functional inspection was performed, and the unit was found to have a released tip (not jammed) and no operational problems were observed during the functional tests performed.No additional contamination was detected inside piece.Additionally, product ifu contains 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".However, complaints of this type will continue to be followed up with periodic reviews to assess if any trends exist.As part of the evaluation, manufacturing, engineering and quality personnel were notified and made aware of the sample received.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "when covering the punch, a green colored particle (the color of the cap) was found stuck to the beginning of the punch, which was going to be inserted into the aorta.So there was a risk of migration into the bloodstream.The utensil was wiped with a damp compress.The particle was set aside".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• 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: 23074826
• Report Number: 3004365956-2025-00055
• Device Sequence Number: 4965959
• Product Code: DWS
• UDI-Device Identifier: 14026704697943
• UDI-Public: (01)14026704697943(11)241118(17)291116(10)74L2400497(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: IPN920986
• Device Catalogue Number: DP-40K
• Device Lot Number: 74L2400497
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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