BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HME THERMOFLO INLINE NEO

    MDR report key: 2645645 · Received July 2, 2012

    Report

    Report Number
    MW5026049
    Event Type
    Malfunction
    Date Received
    July 2, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 2, 2012
    Manufacturer
    ARC MEDICAL INC
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A CALL FROM THE PT'S NURSE LETTING US KNOW THAT THE TRACH NOSES THAT THEY ORDERED WERE NOT THE CORRECT NOSES. WE DISCOVERED THAT THE SHIPPING BOX WAS LABELED WITH THE CORRECT PRODUCT (TRACH NOSE WITH AN OXYGEN ADAPTER ITEM #6220) BUT ACTUALLY CONTAINED A DIFFERENT PRODUCT (DIFFERENT STYLE OF TRACH NOSE WITHOUT AN OXYGEN ADAPTER ITEM #6215A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HME THERMOFLO INLINE NEO TRACH NOSE WITH OXYGEN ADAPTER BYD ARC MEDICAL INC 6220

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO