BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 1080592 · Received July 22, 2008

    Report

    Report Number
    9611451-2008-00444
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Report Date
    June 22, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD IS ALSO SOLD IN THE USA, BUT HAS NO 510(K) AS THIS DEVICE IS CLASSIFIED UNDER CLASS 1. LOT #S GIVEN: 080226, 071205, 080318. ONLY 1 DEVICE WAS RETURNED ALONG WITH 2 EMPTY PACKAGING. DEVICE MFR DATES, RESPECTIVELY: 02/26/2008, 12/05/2007, AND 03/18/2008. METHOD: THE RETURNED DEVICE WAS VISUALLY INSPECTED FOR THE MISSING SUCTION VALVE. RESULTS: THE SILICONE SUCTION VALVE WAS MISSING FROM THE RT021 CATHETER MOUNT AND IT WAS NOT FOUND IN THE OPENED PACKAGING. OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE REC'D FOR THE GIVEN LOT NUMBERS. CONCLUSIONS: THE RT021 CATHETER MOUNT WAS MISSING THE SILICONE SUCTION VALVE. ALL RT021 CATHETER MOUNTS ARE PRESSURE TESTED BEFORE PACKAGING. IF THE VALVE WAS ABSENT DURING THIS TEST, THE RT021 CATHETER MOUNT WOULD FAIL AND SUBSEQUENTLY REJECTED. AS THE VALVE WAS NOT PRESENT IN THE PACKAGING, THE VALVE MUST HAVE FALLEN OUT OF THE RT021 CATHETER MOUNT AFTER PRESSURE TESTING AND PRIOR TO PACKAGING. THIS MAY HAVE OCCURRED DUE TO PRODUCTION OPERATOR ERROR. OUR MONITORING AND TRENDING OF THIS TYPE OF EVENT FOR MISSING SILICONE SUCTION VALVE HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YR OF 0.023%.

    Description of Event or Problem · 1

    A HOSP IN A FOREIGN COUNTRY REPORTED THAT THREE RT021 CATHETER MOUNTS DID NOT HAVE THE SUCTION PORTS. THE SUCTION PORTS COULD NOT BE FOUND IN THE PACKAGING. NO PT CONSEQUENCES WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1