BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON NEBULIZER ADAPTOR 028, SHELFPAK

    MDR report key: 11323753 · Received February 12, 2021

    Report

    Report Number
    3004365956-2021-00039
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 22, 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). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. 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.

    Description of Event or Problem · 0

    COMPLAINT WAS REPORTED "PATIENT HAS A TRACH WITH HIGH HUMIDITY TRACH MASK. PATIENT HAD A RESPIRATORY ARREST SECONDARY TO MUCUS PLUG. THIS HIGH HUMIDITY SET-UP DOES NOT PROVIDE THE SAME AMOUNT OF HUMIDITY AS THE PREVIOUS SET UP. CANNOT DETERMINE THAT THE PRODUCT CAUSED THE MUCUS PLUG AND RESPIRATORY ARREST, HOWEVER, MORE HUMIDIFICATION WOULD HAVE REDUCED THE RISK OF DEVELOPING A MUCUS PLUG". PATIENT HAD A RESPIRATORY ARREST SECONDARY TO MUCUS PLUG. THE TELEFLEX HUMIDITY SET-UP WAS CHANGED TO THE THERA-MIST LVN-HIGH FLOW (SMITHS MEDICAL)SET-UP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. PATIENT CONDITION UNKNOWN.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    COMPLAINT WAS REPORTED "PATIENT HAS A TRACH WITH HIGH HUMIDITY TRACH MASK. PATIENT HAD A RESPIRATORY ARREST SECONDARY TO MUCUS PLUG. THIS HIGH HUMIDITY SET-UP DOES NOT PROVIDE THE SAME AMOUNT OF HUMIDITY AS THE PREVIOUS SET UP. CANNOT DETERMINE THAT THE PRODUCT CAUSED THE MUCUS PLUG AND RESPIRATORY ARREST, HOWEVER, MORE HUMIDIFICATION WOULD HAVE REDUCED THE RISK OF DEVELOPING A MUCUS PLUG". PATIENT HAD A RESPIRATORY ARREST SECONDARY TO MUCUS PLUG. THE TELEFLEX HUMIDITY SET-UP WAS CHANGED TO THE THERA-MIST LVN-HIGH FLOW (SMITHS MEDICAL)SET-UP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. PATIENT CONDITION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218356 HUDSON NEBULIZER ADAPTOR 028, SHELFPAK NEBULIZER (DIRECT PATIENT INTE CAF TELEFLEX MEDICAL IPN049284 14026704627735

    Patients

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