BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NASAL CANNULA CPAP SET, INFANT, SIZE 0

    MDR report key: 2062437 · Received March 18, 2011

    Report

    Report Number
    3004365956-2011-00096
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    February 22, 2011
    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

    DEVICE IS NOT AVAILABLE FOR EVALUATION BY MANUFACTURER. THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. IF SAMPLE BECOMES AVAILABLE OR IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSIONS: NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE ELBOWS ARE CRACKING OR BREAKING WHEN THE CUSTOMER IS TRYING TO PUT THEM IN THE (B)(4). ISSUE WAS DISCOVERED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONALITY TESTING. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NASAL CANNULA CPAP SET, INFANT, SIZE 0 INFANT NASAL CANNULA BZD TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1