BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON INFANT NASAL PRONG CPAP CANNULA

    MDR report key: 1791939 · Received August 4, 2010

    Report

    Report Number
    3004365956-2010-00176
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RETURNED FOR EVALUATION. THE RESULTS OF THE EVALUATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE NARES ON THE CPAP CANNULA KINKED AND COLLAPSED. THE CPAP WAS BEING USED TO ADMINISTER CPAP TREATMENTS ON A PATIENT AT THE TIME THE ALLEGED INCIDENT OCCURRED. THE HUDSON CONCHA NEPTUNE WAS ALSO BEING USED WITH THE CPAP TREATMENTS. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON INFANT NASAL PRONG CPAP CANNULA CPAP CANNULA BZD TELEFLEX MEDICAL NA 02F1000125

    Patients

    Seq Age Sex Outcome Treatment
    1