BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER W/TEE, MOUTHPIECE

    MDR report key: 2171425 · Received June 29, 2011

    Report

    Report Number
    3004365956-2011-00266
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 22, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE PEDIATRIC HEAD NURSE REPORTED THAT A NINE MONTH OLD BABY BOY, NAMED (B)(6), WAS INJURED WHEN RECEIVING ATOMIZATION TREATMENT. THE PT DIDN'T WANT TREATMENT AND GRABBED THE MASK AND BECAUSE THERE WAS A SHARP METAL BURR STICKING OUT, IT STABBED HIS HAND. THE NURSE QUICKLY DISINFECTED THE WOUND. THE PT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON MICRO MIST NEBULIZER W/TEE, MOUTHPIECE NEBULIZER CAF TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO