BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU DP-40K DISP PUNCH 4.0MM

    MDR report key: 12856615 · Received November 22, 2021

    Report

    Report Number
    3004365956-2021-00304
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 3, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DWS
    UDI-DI
    14026704697943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT THE PUNCHED JAMMED WITH TISSUE ATTACHED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT THE PUNCHED JAMMED WITH TISSUE ATTACHED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751212 PU DP-40K DISP PUNCH 4.0MM INSTRUMENTS, SURGICAL, CARDIOV DWS TELEFLEX MEDICAL IPN915270 74E2000382 14026704697943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown