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

Model Number IPN056400

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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 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.

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
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16086357
• MDR Text Key: 308561199
• Report Number: 3004365956-2023-00001
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704714114
• UDI-Public: 14026704714114
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED