BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI/ TELEFLEX

    MDR report key: 1820799 · Received August 26, 2010

    Report

    Report Number
    MW5017248
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 26, 2010
    Manufacturer
    HUDSON RCI / TELEFLEX
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEWBORN IN SPECIAL CARE NURSERY WITH INFANT NASAL CPAP CANNULA SIZE 3 IN USE; NEONATOLOGIST NOTED THE PLASTIC SEEMED THINNER ON SOME PARTS OF THE CANNULA SO, IT WAS TWISTING MORE EASILY AND COULD POSSIBLE CAUSE OCCLUSION. THERE WAS NO HARM TO THE NEWBORN; INVENTORY WAS INSPECTED ON FAMILY BIRTHING CENTER AND RESPIRATORY THERAPY; TELEFLEX REP WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI/ TELEFLEX INFANT NASAL CPAP CANNULA BZD HUDSON RCI / TELEFLEX 00129

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA