BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 5596162 · Received April 21, 2016

    Report

    Report Number
    9611451-2016-00168
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THEREFORE OUR INVESTIGATION IS BASED ON THE PHOTOGRAPHS AND INFORMATION PROVIDED BY THE CUSTOMER, OUR KNOWLEDGE OF THE PRODUCT AND INVESTIGATIONS OF PAST SIMILAR COMPLAINTS. RESULTS: VISUAL INSPECTION OF THE SUPPLIED PHOTOGRAPHS REVEALED THAT THE TUBING CUFF OF THE CATHETER MOUNT HAD SPLIT AT THE SWIVEL END. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF SIMILAR NATURE FOR LOT 150903. CONCLUSION: BASED ON THE INVESTIGATION CONDUCTED, THE SPLIT OBSERVED IS LIKELY DUE TO ENVIRONMENTAL STRESS CRACKING. 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 DISTRIBUTOR IN (B)(4) REPORTED THAT THE TUBING OF AN RT021 CATHETER MOUNT HAD A SPLIT CUFF. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252100 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 150903

    Patients

    Seq Age Sex Outcome Treatment
    1