BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 5931388 · Received September 6, 2016

    Report

    Report Number
    9611451-2016-00504
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 8, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT021 CATHETER MOUNT IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. METHOD: THE COMPLAINT RT021 CATHETER MOUNT WAS RETURNED TO FPH IN (B)(4) FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED. OUR INVESTIGATION IS ALSO BASED ON OUR KNOWLEDGE OF THE PRODUCT AND INVESTIGATIONS OF PAST SIMILAR COMPLAINTS. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF OF THE CATHETER MOUNT HAD SPLIT AT THE CONNECTOR END. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 160127. CONCLUSION: BASED ON THE INVESTIGATION CONDUCTED, THE SPLIT OBSERVED IS LIKELY DUE TO ENVIRONMENTAL STRESS CRACKING CAUSED BY NOT FULLY CURED PRIMER. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED PRIOR TO RELEASE FOR DISTRIBUTION. ANY CATHETER MOUNT WITH A SPLIT TUBE WOULD HAVE FAILED THE PRESSURE TEST AND BE REJECTED FROM THE PRODUCTION LINE. OUR 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 MEDICAL CENTER IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN RT021 CATHETER MOUNT HAD A TEAR ON THE PLASTIC TUBING. THIS WAS DISCOVERED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579761 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 2100021460

    Patients

    Seq Age Sex Outcome Treatment
    1