MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-52K DISP PUNCH 5.2MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number	IPN056400
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: during use on a patient on (b)(6) 2022 during a coronary bypass, the punch had difficulty returning to its initial position.There was no patient consequences.
Event or Problem Description
Reported issue: during use on a patient on (b)(6) 2022 during a coronary bypass, the punch had difficulty returning to its initial position.There was no patient consequences.
Additional Manufacturer Narrative
Qn# (b)(4).One unit of catalog number dp-52k (pu dp-52k disp punch 5.2mm) was received for analysis.Sample wasn't received in its original packaging.No visual defects were observed.No gaps between core and blade were detected.A dimensional inspection was not performed as part of this complaint investigation.The sample was activated several times and it was verified that it's work properly without getting stuck.The sample was operated with a foam and no issues were observed with the cut.The device history record of batch number 74e2100516 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Customer complaint cannot be confirmed since no problem found on sample.

• Brand Name: PU DP-52K DISP PUNCH 5.2MM
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16086357
• Report Number: 3004365956-2023-00001
• Device Sequence Number: 19344064
• Product Code: DWS
• UDI-Device Identifier: 14026704714114
• UDI-Public: 14026704714114
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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 Expiration Date: 05/04/2026
• Device Model Number: IPN056400
• Device Catalogue Number: DP-52K
• Device Lot Number: 74E2100516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown