BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 4339024 · Received December 17, 2014

    Report

    Report Number
    9611451-2014-00937
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 20, 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). METHOD: SIXTEEN RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. OF THE SIXTEEN, TEN WERE FROM LOT 140304 (DATE OF MANUFACTURE 04 MARCH 2014), THREE WERE FROM LOT 140210 (DATE OF MANUFACTURE 10 FEBRUARY 2014), ONE WAS FROM LOT 140327 (27 MARCH 2014) AND NO LOT INFORMATION WAS PROVIDED FOR TWO CATHETER MOUNTS. THREE WERE RETURNED IN UNSEALED BAGS WHILE THIRTEEN WERE RETURNED IN SEALED BAGS. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF ON ALL SIXTEEN RT021 CATHETER MOUNTS WAS SPLIT. EIGHT OF THE CATHETER MOUNTS HAD MULTIPLE SPLITS. THE TUBING CUFF WAS SPLIT AT THE CONNECTOR END ON ELEVEN UNITS AND AT THE SWIVEL END ON FIVE UNITS. THE SWIVEL WAS DISCONNECTED ON TWO CATHETER MOUNTS AND THE CONNECTOR WAS DISCONNECTED ON ANOTHER ONE. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED DEVICES. 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 THE FOLLOWING: "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."

    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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828707 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 140304

    Patients

    Seq Age Sex Outcome Treatment
    1