BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 3801116 · Received May 8, 2014

    Report

    Report Number
    9611451-2014-00409
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 10, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT021 IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. METHOD: THE COMPLAINT RT021 WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) IN AN UNSEALED BAG AND WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE SEAL WAS MISSING FROM THE CATHETER MOUNT. A LOT CHECK WAS NOT PERFORMED AS LOT NUMBER INFORMATION WAS NOT PROVIDED. CONCLUSION: WE ARE UNABLE TO DETERMINE WHETHER THE SEAL WENT MISSING PRIOR TO PACKING OR WHILE AT THE CUSTOMER FACILITY, AS THE RT021 WAS RETURNED IN AN OPENED BAG. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED PRIOR TO PACKING. IF THE SEAL HAD BEEN MISSING, THEN THE DEVICE WOULD HAVE FAILED PRESSURE TESTING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE PORT CAP WAS MISSING FROM AN RT021 CATHETER MOUNT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277694 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021

    Patients

    Seq Age Sex Outcome Treatment
    1