BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CANNUALS, NASAL CPAP, INFANT, SIZE 2

    MDR report key: 2142124 · Received May 26, 2011

    Report

    Report Number
    3004365956-2011-00200
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    May 16, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT REC'D BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE CONNECTOR HAS A CRACK IN THE SAME PLACE ON THE SAME SIDE. THE ALLEGED DEFECT WAS DISCOVERED PRIOR TO USE. THE RESPIRATORY THERAPIST HAD TO OPEN 4 PACKAGES BEFORE FINDING ONE THAT DIDN'T HAVE A CRACK IN IT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CANNUALS, NASAL CPAP, INFANT, SIZE 2 NASAL CPAP BZD TELEFLEX MEDICAL NA 02G1003192

    Patients

    Seq Age Sex Outcome Treatment
    1