BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 3985865 · Received August 6, 2014

    Report

    Report Number
    9611451-2014-00681
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THREE OF THE FOUR COMPLAINT RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING CUFF OF THE THREE CATHETER MOUNTS WAS SPLIT AT THE CONNECTOR END. A LOT CHECK WAS CARRIED OUT FOR TWO OF THE COMPLAINT DEVICES WITH NO OTHER SIMILAR COMPLAINTS FOUND FOR LOT DATE 140213 (13 FEBRUARY 2014). A LOT CHECK WAS CARRIED OUT FOR THE REMAINING COMPLAINT DEVICE (140307, 7 MARCH 2014) AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE TO 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 A SPLIT TUBE WOULD HAVE FAILED THE PRESSURE TEST. THIS SUGGESTS THAT THE RETURNED CATHETER MOUNTS BECAME DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. 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 HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT FOUR RT021 CATHETER MOUNT TUBINGS WERE DAMAGED. TWO OF THE COMPLAINT DEVICES WERE FOUND DAMAGED BEFORE PATIENT USE, AND THE REMAINING TWO WERE FOUND DURING PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459434 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED RT021

    Patients

    Seq Age Sex Outcome Treatment
    1