BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG (BONE INJECTION GUN) PEDIATRIC DEVICE

    MDR report key: 2783842 · Received May 29, 2007

    Report

    Report Number
    9616791-2007-00003
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    January 25, 2007
    Report Date
    May 14, 2007
    Manufacturer
    WAISMED LTD.
    Product Code
    MHC
    PMA / PMN Number
    K022415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT FROM CUSTOMER WAS VAGUE ON ALL ATTEMPTED PHONE CALLS. WE COULD NOT UNDERSTAND WHAT WAS THE DEFINITION OF NOT FIRING PROPERLY. DEVICE HAS SAFETY LATCH THAT NEEDS TO BE REMOVED IN ORDER FOR NEEDLE TO FIRE. CUSTOMER STATES THEY WERE USING IT CORRECTLY. WE DID NOT GET NOTIFIED OF THE EVENT UNTIL (B)(6) 2007. WE INVESTIGATED OUR MANUFACTURING PROCESS, CHECKED VARIOUS LOTS TO SEE IF ANY WERE NOT FUNCTIONING PROPERLY. WE PERFORMED DROP TESTS DIFFERENTLY THAN PREVIOUSLY TO TRY AND CAUSE THE NEEDLE TO DISLODGE FROM INTERNAL HOLDER - AND COULD NOT RECREATE A MISFIRE, DROP TEST OF THE DEVICES IN THEIR BOX COULD NOT RECREATE A LOOSE NEEDLE. WE ARE CHECKING ON POSSIBLE PACKAGING CHANGES TO STRENGTHEN HOLDING THE DEVICE INSIDE THE PACKAGE MAKING ASSUMPTIONS THAT PARAMEDICS HANDLE DEVICES WITH EXTREME ROUGHNESS. WE OFFERED FREE REPLACEMENT OF CUSTOMER'S INVENTORY WITH NEWER STOCK AND OFFER WAS NOT ACCEPTED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DEVICE DID NOT FIRE CORRECTLY OUT OF DEVICE. ADDITIONAL CALLS TO CUSTOMER COULD NOT ASCERTAIN MORE DETAILS OTHER THAN DEVICE DIDN'T FIRE PROPERLY. WE DID NOT GET THE DEVICE BACK (IT WAS DISCARDED ALONG WITH PACKAGING) AND WE WERE NOT INFORMED UNTIL (B)(6) 2007 FROM CUSTOMER AND DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIG (BONE INJECTION GUN) PEDIATRIC DEVICE INTRAOSSEOUS DEVICE MHC WAISMED LTD. WMBIG C2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO