BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG (BONE INJECTION BUG) ADULT MODEL

    MDR report key: 2783834 · Received May 29, 2007

    Report

    Report Number
    9616791-2007-00002
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    March 9, 2007
    Report Date
    May 12, 2007
    Manufacturer
    WAISMED LTD.
    Product Code
    MHC
    PMA / PMN Number
    K981853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE MADE MULTIPLE CALLS TO CUSTOMER TO TRY AND UNDERSTAND HOW DEVICE DID NOT FIRE PROPERLY. WE DID NOT OBTAIN THE DEVICE AND THE CUSTOMER JUST EXPLANTED THAT IT DID NOT FIRE. WE TRIED TO TAKE CUSTOMER THROUGH THE STEPS OF USING THE DEVICE TO SEE IF THIS COULD HELP US UNDERSTAND THE STAGE WHEN IT DID NOT FIRE. WITHOUT THE DEVICE AND NOT KNOWING IF LATCH WAS REMOVED TO ALLOW NEEDLE TO FIRE, WE CANNOT CLEARLY ADDRESS THE PROBLEM. WE DID REPLACED PRODUCT AND OFFER RE-TRAINING. WE ASKED ABOUT HANDLING PROCEDURES AND WAS NOT ABLE TO LEARN MORE FROM CUSTOMER TO UNDERSTAND IF HANDLING WAS A REASON. WE DID CHECKED OUR QC PROCESSES AND THE LOT NUMBER FROM THIS COMPLAINT AND COULD NOT REPEAT THE COMPLAINT. WE RECEIVE REPORT OF THE INCIDENT FROM UNITED STATES DISTRIBUTOR (B)(4) 2007. THEY DID NOT RECEIVE THE REPORT FROM END UNDER ON (B)(4) 2007, BUT ON (B)(4) 2007.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO DISTRIBUTOR ON INITIAL REPORT THAT DEVICE DID NOT FIRE THE RETRACTED NEEDLE PROPERLY. LEARNED FROM DISTRIBUTOR CALLS TO CUSTOMER THAT THE BIG WAS ATTEMPTED TO BE USED TO GAIN IO ACCESS IN AN EMERGENCY PT AND THE DEVICE DID NOT FIRE PROPERLY. NO OTHER DETAILS WERE GIVEN TO UNDERSTAND THE EXACT MEANING OF THIS STATEMENT. DEVICE WAS PLACED ONTO THE SITE OF THE PT AND PARAMEDIC TRIED TO ACTIVATE IT. THEY DID NOT SEE THE NEEDLE EXIT THE DEVICE. THE CUSTOMER DID NOT KEEP THE DEVICE OR ITS PACKAGING TO RETURN FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIG (BONE INJECTION BUG) ADULT MODEL INTRAOSSEOUS DEVICE MHC WAISMED LTD. WMBIG A1 131

    Patients

    Seq Age Sex Outcome Treatment
    1