BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PRONGS INFANT SMALL 20/CS

    MDR report key: 2404767 · Received January 9, 2012

    Report

    Report Number
    8030673-2012-00068
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K050994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER RETURNED SAMPLE WAS EVALUATED ACCORDING TO INSPECTION PROCEDURES AND IT WAS OBSERVED THAT THE PRONG TIPS ARE BREAKING; THE REPORTED ISSUE WAS CONFIRMED. UNFORTUNATELY WITHOUT THE LOT NUMBER INFORMATION, IT IS NOT POSSIBLE TO REVIEW THE DEVICE HISTORY RECORD FOR THIS PRODUCT. THE PART NUMBER INVOLVED IS NOT CURRENTLY BEING MANUFACTURED AND THEREFORE THE MANUFACTURING PROCESS COULD NOT BE REVIEWED. THE NASAL PRONG COMPONENT OF THIS PRODUCT IS PROVIDED BY AN EXTERNAL SUPPLIER. CAREFUSION HAS NOTIFIED THE EXTERNAL SUPPLIER AND REQUESTED THEIR INVESTIGATION INTO THE ROOT CAUSE AND CORRECTIVE ACTION FOR THE PROBLEM REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO CAREFUSION THAT A PRONG FROM AIRLIFE INFANT NASAL PRONGS BROKE OFF AND LODGED IN THE PATIENT'S NARE. THE CLINICIAN HAD TO REMOVE THE BROKEN PRONG FROM THE NARE. THE PATIENT WAS A (B)(6) MALE INFANT BEING TREATED FOR RESPIRATORY DISTRESS SYNDROME. THE SAMPLE IS AVAILABLE AND THE CUSTOMER HAS INDICATED IT WILL BE RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS UNINJURED AND FULLY RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL PRONGS INFANT SMALL 20/CS CATHETER, NASAL, OXYGEN BZD CAREFUSION 006910-A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA