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

Model Number	IPN915270
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The customer states that the punched jammed with tissue attached.The patient's condition was reported as fine.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74e2000382 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance 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.Manufacture date: 2020-05-07.Expiration date: 2022-05-06.One unit of catalog number dp-40k (pu dp-40k disp punch 4.0mm) was received for analysis.Sample wasn't received in its original packaging.It was observed residues at the core and at the blade of the aortic punch.After trying to perform the functional test, the sample was disassembled in order to review and clean the blade and the core.A portion of tissue was expelled from the unit.The core p/n 158910 was dimensional inspected per dwg-pun-002 rev.03.No dimensional issues were found.See qa-pun-002/f3 rev.07 for more details.The blade p/n 146975 was dimensional inspected per dwg-pun-002 rev.03.No dimensional issues were found.See qa-pun-001/f2 rev.06 for more details.The ifu l02984 r02 contain some warnings about the care and proper use of product.The warning number 3 and 4 say the following: "3.Remove the punch from the operative site slowly before releasing and removing the excised tissue.", "4.Remove the excised tissue before additional openings are created.Failure to remove excised tissue from the punch or excessive cleaning may cause punch jamming or incomplete cuts." a portion of tissue was expelled from the unit.This indicated that the warning 3 and 4 from ifu l02984 r02 was not followed.(see ifu l02984 r02.).Customer complaint cannot be confirmed as manufacturing issue related.The jamming observed on sample was originated by the excised tissue that was not removed per ifu l02984 r02.
Event or Problem Description
The customer states that the punched jammed with tissue attached.The patient's condition was 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12856615
• Report Number: 3004365956-2021-00304
• Device Sequence Number: 3874574
• Product Code: DWS
• UDI-Device Identifier: 14026704697943
• UDI-Public: 14026704697943
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 05/06/2022
• Device Model Number: IPN915270
• Device Catalogue Number: DP-40K
• Device Lot Number: 74E2000382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• 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
• Patient Sex: Unknown