BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NASAL CANNULA, CPAP SET, INFANT, SIZE 1

    MDR report key: 2093297 · Received April 15, 2011

    Report

    Report Number
    3004365956-2011-00157
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 24, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE PRONGS ON THE CPAP ARE TOO SOFT AND EASILY DISLODGES FROM THE NASAL AREA AND COULD RESULT IN NASAL TRAUMA. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NASAL CANNULA, CPAP SET, INFANT, SIZE 1 INFANT NASAL CANNULA BZD TELEFLEX MEDICAL NA 02E10001841

    Patients

    Seq Age Sex Outcome Treatment
    1