BEUDAMED
    FDA Adverse Event Other Summary report: N

    NASAL ATOMIZATION DEVICE

    MDR report key: 6050407 · Received October 20, 2016

    Report

    Report Number
    MW5065552
    Event Type
    Other
    Date Received
    October 20, 2016
    Report Date
    July 7, 2016
    Manufacturer
    TELEFLEX
    Product Code
    CCQ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I'M THE OUTPATIENT PHARMACY MANAGER AT (B)(6) HOSPITAL. I'M REPORTING AN ISSUE WITH A DEVICE, THE MAD NASAL INTRANASAL MUCOSAL ATOMIZATION DEVICE. WE DISPENSE THIS DEVICE TO OUTPATIENTS ALONG WITH MIDAZOLAM VIALS FOR INTRANASAL ADMINISTRATION TO TREAT SEIZURES. WE HAVE HAD 2 PTS REPORT THAT THE DEVICE THEY RECEIVED FROM US WAS MISSING THE VIAL ADAPTER PIECE. WITHOUT THIS PIECE THE MIDAZOLAM VIAL COULD NOT BE PUNCTURED AND THEREFORE, THE MEDICATION NOT ADMINISTERED. BOTH FAMILIES HAD ANOTHER DEVICE TO USE SO THE MISSING VIAL ADAPTER DID NOT RESULT IN A MISSED DOSE. LAST WEEK WE DISCOVERED ANOTHER DEVICE WAS MISSING THE VIAL ADAPTER COVER WHEN ONE OF OUR EMPLOYEES WAS STOCKING THE DEVICES AND WAS POKED BY THE VIAL ADAPTER. I HAVE REPORTED THIS TO THE VENDOR. THE PICTURE HAS THE VIAL ADAPTER (BLUE) BUT IS MISSING THE COVER. ALSO THE F/U LETTER I RECEIVED FROM TELEFLEX AFTER REPORTING THE MISSING COVER. WE HAVE REVIEWED OUR CURRENT STOCK AND DIDN'T FIND ANY OTHER DEVICES WITH MISSING COVERS OR VIAL ADAPTERS. I'VE CONTACTED OR ATTEMPTED TO CONTACT THE PARENTS OF PTS WHO HAVE RECEIVED THE DEVICE FROM US RECENTLY AND ASKED THEM TO EXAMINE THEIR DEVICES FOR MISSING VIAL ADAPTERS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696143 NASAL ATOMIZATION DEVICE ATOMIZER CCQ TELEFLEX
    696144 NASAL ATOMIZATION DEVICE ATOMIZER CCQ TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1