BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 4367924 · Received December 29, 2014

    Report

    Report Number
    9611451-2014-00949
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 4, 2014
    Report Date
    December 4, 2014
    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). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED DEVICES: RT021, LOT 140623, DATE OF MANUFACTURE: 23 JUNE 2014, RT021, LOT 140225, DATE OF MANUFACTURE: 25 FEBRUARY 2014, RT021, LOT 140210, DATE OF MANUFACTURE: 10 FEBRUARY 2014,. RT021, LOT 140304, DATE OF MANUFACTURE: 04 MARCH 2014 METHOD: FOUR RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF WAS SPLIT AT THE SWIVEL END ON THREE RT021 CATHETER MOUNTS. STRESSMARKS WERE NOTED ON THE TUBING CUFF NEAR THE CONNECTOR ON ONE OF THE DEVICES . ON THE RT021 FROM LOT 140623 THE CONNECTOR WAS FOUND DETACHED AND THE SWIVEL WAS DETACHED ON THE ONE FROM LOT 140210 . CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED RT021 CATHETER MOUNTS. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CATHETER MOUNT WITH DAMAGED TUBING WOULD HAVE FAILED THE PRESSURE TEST. THIS SUGGESTS THAT THE RETURNED DEVICES WERE DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT021 CATHETER MOUNT STATE: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE" "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTION TO A PATIENT."

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE TUBING ON FOUR RT021 CATHETER MOUNTS WAS DAMAGED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE TUBING ON FOUR RT021 CATHETER MOUNTS WAS DAMAGED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856390 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 140210

    Patients

    Seq Age Sex Outcome Treatment
    1