BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG (BONE INJECTION GUN) PEDIATRIC MODEL

    MDR report key: 2783831 · Received May 29, 2007

    Report

    Report Number
    9616791-2007-00004
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    March 31, 2007
    Report Date
    May 15, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITH FURTHER CALLS TO THE END USER WE TRIED TO OBTAIN MORE DESCRIPTIVE DETAILS. WE ASKED ABOUT HOW THE DEVICE WAS USED. WE ASKED ABOUT THE STEPS TAKEN TO USE THE DEVICE. IT WAS UNCLEAR FROM THE CUSTOMER WHETHER THE SAFETY LATCH HAD BEEN REMOVED BEFORE ACTIVATING DEVICE. WITHOUT SAFETY LATCH REMOVED, YOU CANNOT FIRE DEVICE. IT SEEMS THAT THE USER MAY NOT HAVE REMOVED THE SAFETY LATCH BEFORE OPERATING, THEREFORE THE DEVICE WAS NOT TRIGGERED TO DISCHARGE THE NEEDLE. THE USER DISCARDED DEVICE AND DIDN'T SEND IT FOR INSPECTION. WE OFFERED RE-TRAINING TO THE CUSTOMER. WE REPLACED PRODUCT WITH NEW AS GOODWILL GESTURE. WE ASKED CUSTOMER TO PROVIDE US MORE INFO FROM FIELD PERSONNEL WHO ACTUALLY USED DEVICE ON DATE OF INCIDENT TO FURTHER PROVIDE US WITH STEPS USED. WE DID NOT RECEIVE REPORT OF THE INCIDENT FROM UNITED STATES DISTRIBUTOR AND CUSTOMER UNTIL (B)(4) 2007. DISTRIBUTOR DID NOT RECEIVE THE REPORT FROM END USER (CUSTOMER) ON (B)(6) 2007 BUT ON (B)(6) 2007. WE HAVE ATTEMPTED MANY TIMES WITHIN THE LAST 30 DAYS TO OBTAIN MORE DETAILS SINCE THE INITIAL REPORT FROM CUSTOMER IS SO VAGUE AND DID NOT PROVIDE US SIGNIFICANT INFORMATION TO CONDUCT THOROUGH INVESTIGATION WITHOUT ACTUAL DEVICE RETURNED.

    Description of Event or Problem · 1

    INITIAL REPORT FROM DISTRIBUTOR STATED THAT THE BIG WAS ATTEMPTED FOR USE TO GAIN IO ACCESS IN AN EMERGENCY PT AND THE DEVICE DID NOT FIRE PROPERLY. IT WAS STATED THAT THE NEEDLE WAS RETRACTED INSIDE THE DEVICE AND DID NOT COME OUT. DEVICE WAS PLACED ONTO THE SITE OF THE PT AND PARAMEDIC TRIED TO ACTIVATE IT. THEY DID NOT SEE THE NEEDLE EXIT THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1