BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 1897133 · Received November 11, 2010

    Report

    Report Number
    9611451-2010-00670
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 26, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE COMPLAINT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. METHOD: THE COMPLAINT BREATHING CIRCUIT KIT IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. PHOTOGRAPHS OF THE COMPLAINT DEVICE HAS BEEN PROVIDED BY THE COMPLAINANT. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS, THE PHOTOGRAPHS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: A VISUAL INSPECTION OF THE PHOTOGRAPHS PROVIDED CONFIRMED THAT THE PRODUCT LABEL WAS MISSING FROM THE PACKAGING BAG OF THE BREATHING CIRCUIT KIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: EACH BREATHING CIRCUIT KIT CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. THE LABELS ARE ATTACHED TO THE KITS BY AN OPERATOR ON THE PRODUCTION LINE. IT IS LIKELY THAT OPERATOR ERROR HAS RESULTED IN THE OMITTED LABEL. THERE ARE STANDARD OPERATING PROCEDURES IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE TO CORRECTLY PACK BREATHING CIRCUITS. INSTRUCTIONS INCLUDE PACKING THE CIRCUITS 'TOP AND TAIL' ALTERNATELY, WITH LABELS FACING AWAY FROM THE FRONT OF THE BOX. HOWEVER, IN THIS INSTANCE, THE MISSING LABEL WAS OVERLOOKED. (B)(4)..

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT A LABEL WAS FOUND TO BE MISSING FROM AN RT126 INFANT LOW FLOW BREATHING CIRCUIT DURING AN INWARDS GOODS INSPECTION. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT LOW FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT126 100729

    Patients

    Seq Age Sex Outcome Treatment
    1