BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER MOUNT

    MDR report key: 5352574 · Received January 7, 2016

    Report

    Report Number
    9611451-2016-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 11, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT021 IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. THE COMPLAINT RT021 CATHETER MOUNTS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT021 IS SOLD IN THE USA BUT HAS NO 510(K) NUMBER AS IT IS CONSIDERED A CLASS I DEVICE. METHOD: FURTHER INFORMATION FROM THE CUSTOMER WAS RECEIVED: FOR 23 RT021 CATHETER MOUNTS, THE END OF THE HOSE WAS ALLEGEDLY FOUND TORN AND FOR 18 RT021 CATHETER MOUNTS, THE END OF THE HOSE WAS ALLEGEDLY FOUND DETACHED. ONLY SIX COMPLAINT RT021 CATHETER MOUNTS WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED, THE OTHER REMAINING COMPLAINT UNITS WERE DISCARDED BY THE CUSTOMER AND WERE NOT AVAILABLE FOR AN INVESTIGATION BY FPH. THEREFORE, FPH IS NOT ABLE TO CONFIRM THE REPORTED EVENT FOR ALL REPORTED COMPLAINT UNITS. RESULTS: VISUAL INSPECTION REVEALED THAT THREE RETURNED DEVICES (3X LOT 150610, MANUFACTURED ON 10 JUNE 2015) HAD DETACHED CONNECTORS. VISUAL INSPECTION OF THE OTHER THREE RETURNED DEVICES (3X LOT 150821, MANUFACTURED ON 21 AUGUST 2015) REVEALED THAT FOR ONE UNIT THE TUBING CUFF AT THE SWIVEL END WAS SPLIT AND FOR TWO UNITS THE TUBING CUFF AT THE CONNECTOR END WAS SPLIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150610 AND NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150821. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED RT021 CATHETER MOUNTS WITH DETACHED CONNECTORS. THE NATURE OF THE DAMAGE OBSERVED ON THE RT021 CATHETER MOUNTS WITH SPLIT TUBING CUFFS SUGGESTS THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING. ALL RT021 CATHETER MOUNTS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT021 CATHETER MOUNTS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. 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.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE "END OF THE HOSE WAS TORN OR DETACHED ON THE RT021 CATHETER MOUNTS". THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE "END OF THE HOSE WAS TORN OR DETACHED ON THE RT021 CATHETER MOUNTS". THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10449 CATHETER MOUNT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT021 150610

    Patients

    Seq Age Sex Outcome Treatment
    1