BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU DP-48K DISP PUNCH 4.8MM

    MDR report key: 6979735 · Received October 26, 2017

    Report

    Report Number
    3004365956-2017-00373
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 10, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED TO 1 PIECE FROM PRODUCT CODE (B)(4) RECEIVED AS PART OF THIS COMPLAINT, SAMPLE WAS RECEIVED IN THEIR CORRESPONDING WRAPPING (POUCH) AND SEALED POUCH. DIMENSIONAL TESTS ACCORDING TO QA-PUN-001/F2 AND F3 WERE PERFORMED OBTAINED ACCEPTABLE RESULTS IN CORE AND BLADE PARTS. FUNCTIONAL TEST WAS PERFORMED ACCORDING TO QA-PUN-003/F1 TO THE UNIT OBTAINING ACCEPTABLE RESULTS. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE THE DIMENSIONAL AND FUNCTIONAL TEST DEMONSTRATED THAT PRODUCT IS ACCORDING TO SPECIFICATION. CUSTOMER COMPLAINT IS NOT CONFIRMED DUE THE DHR REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO THE REPORTED FAILURE MODE NEITHER ON THE PRODUCT OR ITS COMPONENTS DURING THE MANUFACTURE OF THIS MATERIAL ALSO CLOSED SAMPLE RECEIVED DEMONSTRATED ARE ACCORDING TO SPECIFICATIONS. RESULTS - NO RESULT CODE AVAILABLE THAT COULD ACCURATELY DESCRIBE THAT THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER PROVIDED HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO REJECTION REPORT WAS ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DEVICE HISTORY REVIEW SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KIDNEY TRANSPLANT IT WAS INTENDED TO TAKE A TISSUE SAMPLE. DURING THE ATTEMPT TO REMOVE THE TISSUE SAMPLE THE DISPOSABLE AORTA PUNCH JAMMED AND COULD NOT BE TRIGGERED 100%. THE PRODUCT WAS UNFORTUNATELY DISPOSED OF, A REPRESENTATIVE PRODUCT WITH THE SAME LOT WILL BE RETURNED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KIDNEY TRANSPLANT IT WAS INTENDED TO TAKE A TISSUE SAMPLE. DURING THE ATTEMPT TO REMOVE THE TISSUE SAMPLE THE DISPOSABLE AORTA PUNCH JAMMED AND COULD NOT BE TRIGGERED 100%. THE PRODUCT WAS UNFORTUNATELY DISPOSED OF, A REPRESENTATIVE PRODUCT WITH THE SAME LOT WILL BE RETURNED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761604 PU DP-48K DISP PUNCH 4.8MM DWS TELEFLEX MEDICAL 74D1702443

    Patients

    Seq Age Sex Outcome Treatment
    1