BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1498508 · Received September 3, 2009

    Report

    Report Number
    9611451-2009-00480
    Event Type
    Malfunction
    Date Received
    September 3, 2009
    Date of Event
    August 2, 2009
    Report Date
    August 12, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K20332. THE RETURNED BREATHING CIRCUIT WAS VISUALLY EXAMINED. RESULTS: THREE SMALL CUTS WERE FOUND ON THE EXPIRATORY LIMB. THE CUTS WERE ALIGNED ON ONE EDGE OF THE CORRUGATION. THE DIRECTIONAL NATURE OF THE CUTS SUGGESTS THAT THE DAMAGE WAS CAUSED BY A SHARP OBJECT SUCH AS A KNIFE. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS SUPPLIED. CONCLUSION: IT IS MOST LIKELY THAT THE CUTS WERE CAUSED DURING THE OPENING OF THE CIRCUIT PACKAGING. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS ON THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. AT THE PACK BAG STATION, THE CIRCUIT KITS ARE ALSO VISUALLY INSPECTED FOR ANY DEFECTS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THEY FOUND A CUT ON THE EXPIRATORY LIMB OF A RT125 INFANT BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT125

    Patients

    Seq Age Sex Outcome Treatment
    1