BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT NASAL CPAP CANNULA, SIZE 3

    MDR report key: 1860402 · Received September 27, 2010

    Report

    Report Number
    3004365956-2010-00263
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN REC'D BY MFR FOR EVAL. THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THE PRONGS ARE TOO SOFT AND THE ELBOWS DON'T STAY IN THE CANNULA BRIDGE. THIS AFFECTS THE ABILITY TO DELIVER NCPAP TO THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT NASAL CPAP CANNULA, SIZE 3 NASAL CANNULA BZD TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1