BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 3483053 · Received November 22, 2013

    Report

    Report Number
    9611451-2013-00937
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    October 23, 2013
    Report Date
    October 23, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).METHOD: TWO RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY EXAMINED. ONE OF THE RETURNED RT021 WAS FROM LOT 120926 AND THE LOT INFORMATION FOR THE OTHER RT021 WAS NOT PROVIDED.RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF AT THE CONNECTOR END OF THE CATHETER MOUNT WAS SPLIT ON THE RT021 FROM LOT 120926. THE TUBING CUFF WAS SPLIT AT THE SWIVEL END ON THE OTHER RT021 CATHETER MOUNT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120926.CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE OBSERVED ON THE RETURNED RT021 CATHETER MOUNTS. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CATHETER MOUNT WITH A SPLIT TUBE WOULD HAVE FAILED THE PRESSURE TEST. THIS SUGGESTS THAT THE RETURNED CATHETER MOUNTS WERE DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT021 CATHETER MOUNT STATE THE FOLLOWING:"CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE";"PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT".

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT TWO RT021 CATHETER MOUNTS WERE BROKEN. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611072 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 120926

    Patients

    Seq Age Sex Outcome Treatment
    1