BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PRONGS INFANT SMALL 20/CS

    MDR report key: 2420534 · Received January 18, 2012

    Report

    Report Number
    8030673-2012-00075
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    January 11, 2010
    Report Date
    January 11, 2010
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K050994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE RECEIVED FOR EVALUATION SHOWED COMPONENT PART NUMBER 60-616 TO BE BROKEN. HOWEVER, WITHOUT A LOT NUMBER, THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. THE ROOT CAUSE OF (B)(4) TEARING EASILY WAS REQUESTED FROM THE SUPPLIER AS WELL AS CORRECTIVE ACTION. THE SUPPLIER INDICATED THAT THEY MEASURED THE THICKNESS AT THE LOCATION OF THE REPORTED TEAR ON 32 RANDOM INVENTORY SAMPLES. ALL SAMPLES WERE FOUND TO BE WITHIN SPECIFICATIONS. THE SUPPLIER ALSO INDICATED THAT THEY TRAINED VISUAL INSPECTION PERSONNEL ON IDENTIFICATION OF THE TEAR. CAREFUSION 2200 INC. POST-MARKET SURVEILLANCE WAS HISTORICALLY MANAGED BY CARDINAL HEALTH VIA A TRANSITIONAL SERVICE AGREEMENT FROM SEPTEMBER 1, 2009, THROUGH JULY 1, 2011, SINCE CAREFUSION OFFICIALLY SPUN OFF FROM CARDINAL HEALTH AS OF SEPTEMBER 1, 2009. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION CUSTOMER ADVOCACY CLINICAL TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Description of Event or Problem · 1

    THE NASAL PRONG TORE AT THE ARTICULATING ELBOW WHEN BEING REMOVED FROM THE BABY AND THE PRONG WAS LEFT IN THE BABY'S SNARE BUT REMOVED WITHOUT INCIDENT. THE CUSTOMER FEELS THEY TEAR TOO EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL PRONGS INFANT SMALL 20/CS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD CAREFUSION 006910-A 09J09989

    Patients

    Seq Age Sex Outcome Treatment
    1