BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIG (BONE INJECTION GUN) ADULT MODEL

    MDR report key: 2760119 · Received May 29, 2007

    Report

    Report Number
    9616791-2007-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    February 2, 2007
    Report Date
    May 15, 2007
    Manufacturer
    WAISMED LTD
    Product Code
    MHC
    PMA / PMN Number
    K981853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CONTACTED DISTRIBUTOR (B)(6) 2007 TO REPORT DEVICE FAILURE. DISTRIBUTOR CONTACTED MANUFACTURER (B)(6) 2007. WAISMED HAS BEEN TRYING TO RECREATE BY MANY DIFFERENT TESTS AND ANALYSIS. WE HAVE INVESTIGATED PACKAGING, EXTREME HANDLING, DROP TESTS, ORIGINAL ASSEMBLY DESIGNS. ALL OF THESE ARE BEING LOOKED AT TO SEE IF FAILURE CAN BE RECREATED. WE HAVE NOT RECREATED NEEDLE FALLING OUT. HOWEVER, WE ARE WORKING TO IMPROVE PACKAGING SINCE PARAMEDICS HANDLING CAN BE ROUGH. NEW PACKAGING SAMPLES HAVE BEEN ORDERED TO SEE IF THE PACKAGE CAN BE AN IMPROVEMENT. REVIEW OF INTERNAL NEEDLE HOLDING MECHANISM HAS BEEN CHECKED AND THE ASSEMBLY PROCESS REVIEWED. INCREASED FINISHED GOODS QC CHECKS HAVE BEEN IMPLEMENTED. WE HAVE RECOMMENDED TO THE CUSTOMER TO CARRY TWO DEVICES AS BACKUP SINCE CUSTOMER STATED THEY DID NOT HAVE SECOND UNIT IN THEIR BAG. CUSTOMER HAS IMPLEMENTED NEW PROTOCOL TO HAVE VARIOUS BACKUP EQUIPMENT FOR IO ACCESS.

    Description of Event or Problem · 1

    PARAMEDIC ON SITE STATED THAT DURING TREATMENT OF A PT IN CARDIAC ARREST, VEIN LINE ATTEMPTS FAILED THEREFORE HE DECIDED TO ESTABLISH AN IO LINE. CUSTOMER REPORTED THAT WHEN OPENING THE DEVICE PACKAGE, THE NEEDLE WAS NOT ATTACHED (WAS LOOSE) FELL OUT OF PACKAGE PRIOR TO USE. DEVICE WAS NEVER USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIG (BONE INJECTION GUN) ADULT MODEL INTRAOSSEOUS DEVICE MHC WAISMED LTD WMBIGA1 103

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR