BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT NASAL CANNULA OXYGEN THERAPY

    MDR report key: 1850821 · Received October 3, 2010

    Report

    Report Number
    9611451-2010-00609
    Event Type
    Malfunction
    Date Received
    October 3, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED CANNULA WAS VISUALLY INSPECTED FOR DAMAGE OR ABNORMALITIES. RESULTS: THE CANNULA TUBING WAS FOUND TO BE DISCONNECTED FROM THE NASAL INTERFACE, CONFIRMING THE REPORTED FAULT. THERE WAS NO RESIDUE ON THE TUBING AND NO DAMAGE TO THE SURFACE OF THE TUBING. A LOT CHECK COULD NOT BE CARRIED OUT AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THERE WAS NO RESIDUE ON THE TUBING. THIS SUGGESTS THAT THERE WAS NO BONDING AGENT OR AN INSUFFICIENT AMOUNT OF BONDING AGENT APPLIED TO THE CANNULA DURING MANUFACTURING. AS THERE WAS NO DAMAGE TO THE SURFACE OF THE TUBING, IT IS LIKELY THAT ANY BONDING MATERIAL APPLIED HAD NOT BONDED PROPERLY, AS A BOND BROKEN BY FORCE WILL DAMAGE THE TUBE SURFACE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE TUBING ON A BC2745 INFANT NASAL CANNULA "KEPT DETACHING FROM THE CANNULA ITSELF." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT NASAL CANNULA OXYGEN THERAPY CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED BC2745-20 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1