BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 5249248 · Received November 25, 2015

    Report

    Report Number
    9611451-2015-00498
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    October 23, 2015
    Report Date
    October 26, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: SEVEN RT021 CATHETER MOUNTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. ONE OF THE RETURNED DEVICES WAS FROM LOT 130322 (DATE OF MANUFACTURE 22 MARCH 2013); TWO WERE FROM LOT 130522 (DATE OF MANUFACTURE 22 MAY 2013) AND NO LOT INFORMATION WAS PROVIDED FOR THE REMAINING FOUR DEVICES. RESULTS: VISUAL INSPECTION REVEALED THAT THREE OF THE DEVICES WITH NO LOT INFORMATION WERE RETURNED WITH THE CONNECTOR SEPERATED. THE CONNECTOR WAS FOUND LOOSE ON THE REMAINING DEVICES. A SUFFICIENT AMOUNT OF GLUE WAS NOTED INSIDE THE CUFF AND ON THE OUTSIDE OF THE CONNECTOR ON ALL OF THE RETURNED DEVICES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOTS 130322 & PS130522. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED RT021 CATHETER MOUNTS. ALL RT021 CATHETER MOUNTS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO PACKING, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE OBSERVED DAMAGE OCCURRED AFTER THE DEVICES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE CONNECTORS ON TWO RT021 CATHETER MOUNTS DETACHED FROM THE TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN FINLAND REPORTED THAT THE CONNECTORS ON TWO RT021 CATHETER MOUNTS DETACHED FROM THE TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780691 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 130322

    Patients

    Seq Age Sex Outcome Treatment
    1