BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITRUNK INFANT INTERFACE NASAL TUBING

    MDR report key: 3625657 · Received February 12, 2014

    Report

    Report Number
    9611451-2014-00120
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 16, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BC191 FLEXITRUNK INFANT INTERFACE NASAL TUBING WAS RETURNED TO FPH IN (B)(6) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE BREATHABLE FILM OF ONE OF THE TUBES WAS STRETCHED BETWEEN THE THIRD AND FIFTH SPIRAL FROM THE DISTAL CONNECTOR. BOTH TUBES WERE ALSO FOUND DETACHED FROM ITS CONNECTORS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130719. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED DAMAGE. HOWEVER, OUR PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS HAVE SHOWN THAT SUCH PROBLEM HAS BEEN CAUSED BY ROUGH HANDLING OF THE NASAL TUBING. ALL FLEXITRUNK INFANT NASAL TUBINGS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE, AND ANY HOLES OR LEAKS ARE IDENTIFIED DURING THIS PROCESS. NASAL TUBINGS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE SUBJECT NASAL TUBING WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE FLEXITRUNK INFANT INTERFACE ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE NASAL TUBINGS, AND STATE THE FOLLOWING: "HANDLE WITH CARE. USE CAUTION WHEN POSITIONING OR DISCONNECTING THE INFANT INTERFACE. AVOID EXCESSIVE PULL FORCES, SHARP OBJECTS AND TUBING HOLDERS. DAMAGE TO THE TUBING MAY CAUSE LOSS OF PRESSURE AND REQUIRE IMMEDIATE REPLACEMENT." A CAUTION INSERT IS ALSO INCLUDED IN THE PACKAGING TO REMIND THE USER TO TAKE EXTRA CARE WHEN HANDLING THE FLEXITRUNK INFANT INTERFACE PRODUCTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WHITE CONNECTOR OF A BC191 FLEXITRUNK INFANT INTERFACE NASAL TUBING WAS DISLODGED FROM THE RIBBED TUBING. THIS WAS OBSERVED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93723 FLEXITRUNK INFANT INTERFACE NASAL TUBING BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED BC191 130719

    Patients

    Seq Age Sex Outcome Treatment
    1