BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON INFANT NASAL CPAP CANNULA, SIZE 2

    MDR report key: 3820835 · Received April 15, 2014

    Report

    Report Number
    3004365956-2014-00165
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RECEIVED YET AS OUR FACILITY. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS MOMENT SINCE THE DEFECTIVE SAMPLE OR A PICTURE OF IT ARE AVAILABLE FOR EVALUATION. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. IF THE PHYSICAL SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE NASAL CANNULA HAS A GREASY TEXTURE AND ONCE THE CANNULA HAS WARMED IT BEGINS TO FALL OFF ON EITHER SIDE OF THE NASAL PRONGS. THE CANNULA WAS EXCHANGED FOR ANOTHER ONE. THE PATIENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230662 HUDSON INFANT NASAL CPAP CANNULA, SIZE 2 NASAL CPAP CANNULA CAT TELEFLEX 02B1400072

    Patients

    Seq Age Sex Outcome Treatment
    1