BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON NEBULIZER ADAPTOR 028, SHELFPAK

    MDR report key: 11558040 · Received March 23, 2021

    Report

    Report Number
    3004365956-2021-00104
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 3, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    UDI-DI
    14026704627735
    PMA / PMN Number
    K141214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS ALSO PERFORMED AND NO ISSUES WERE ENCOUNTERED. THE COMPLAINT COULD NOT BE CONFIRMED. NO ISSUES WERE FOUND WITH THE RETURNED SAMPLE. THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE PRODUCT WAS IN PLACE 3 DAYS WHEN THE RT WAS CALLED TO THE BEDSIDE OF A TRACH PATIENT WHO WAS COUGHING AND STRUGGLING TO EXPECTORATE. ON ARRIVAL, THE RT NOTED VERY DRY SECRETIONS WHICH WERE UNABLE TO BE SUCTIONED EASILY WITHOUT INSTILLING SALINE TO LOOSEN THEM. AT ONE POINT THE PATIENT COUGHED SO FORCEFULLY THAT THE TRACH SUTURES POPPED OUT. ON INSPECTION OF THE AEROSOL HUMIDITY, THE NEBULIZER WAS NOTED AS MALFUNCTIONING, I.E. NO AEROSOLIZATION OCCURRING DESPITE CORRECT SETUP OF THE EQUIPMENT AND A FULL WATER BOTTLE. HE TOOK THE NEBULIZER OFF THE BOTTLE, DIDN'T NOTE ANY OBVIOUS ISSUES WITH IT, RETHREADED IT ON A NEW BOTTLE AND SPIKED IT BUT IT WAS STILL NOT PRODUCING AEROSOL HUMIDITY". IT WAS REPORTED NO RESUSCITATION EFFORTS WERE REQUIRED. PATIENT CONDITION REPORTED TO BE "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE PRODUCT WAS IN PLACE 3 DAYS WHEN THE RT WAS CALLED TO THE BEDSIDE OF A TRACH PATIENT WHO WAS COUGHING AND STRUGGLING TO EXPECTORATE. ON ARRIVAL, THE RT NOTED VERY DRY SECRETIONS WHICH WERE UNABLE TO BE SUCTIONED EASILY WITHOUT INSTILLING SALINE TO LOOSEN THEM. AT ONE POINT THE PATIENT COUGHED SO FORCEFULLY THAT THE TRACH SUTURES POPPED OUT. ON INSPECTION OF THE AEROSOL HUMIDITY, THE NEBULIZER WAS NOTED AS MALFUNCTIONING, I.E. NO AEROSOLIZATION OCCURRING DESPITE CORRECT SETUP OF THE EQUIPMENT AND A FULL WATER BOTTLE. HE TOOK THE NEBULIZER OFF THE BOTTLE, DIDN'T NOTE ANY OBVIOUS ISSUES WITH IT, RETHREADED IT ON A NEW BOTTLE AND SPIKED IT BUT IT WAS STILL NOT PRODUCING AEROSOL HUMIDITY". IT WAS REPORTED NO RESUSCITATION EFFORTS WERE REQUIRED. PATIENT CONDITION REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452789 HUDSON NEBULIZER ADAPTOR 028, SHELFPAK NEBULIZER (DIRECT PATIENT INTE CAF TELEFLEX MEDICAL IPN049284 UNKNOWN 14026704627735

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R NONE REPORTED| NONE REPORTED