BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SOFTECH PLUS ADULT CANNULA,7' GRN STAR-

    MDR report key: 12531150 · Received September 26, 2021

    Report

    Report Number
    3011137372-2021-00252
    Event Type
    Malfunction
    Date Received
    September 26, 2021
    Date of Event
    September 2, 2021
    Report Date
    September 2, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAT
    UDI-DI
    14026704625243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. MANUFACTURER CHECKED THE FIRST RETAINED SAMPLE FROM THE SAME BATCH, 200725-1 AND FOUND NO ABNORMALITY. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED. 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 · 1

    IT WAS REPORTED THAT:" HUDSON RCI ADULT SOFTECH PLUS NASAL CANNULA. THESE DON'T SEEM TO BE FITTING THE PATIENTS WELL. THEY WON'T STAY IN PLACE DESPITE WHICH WAY THEY ARE PLACED. THIS THEN BECOMES UNCOMFORTABLE FOR THE PATIENT AND REDUCES THE THERAPEUTIC SIGNIFICANCE". NO PATIENT HARM OR INJURY REPORTED. DEVICE WAS EXCHANGED FOR AN OXYGEN MASK. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428489 HUDSON SOFTECH PLUS ADULT CANNULA,7' GRN STAR- CANNULA, NASAL, OXYGEN CAT TELEFLEX MEDICAL IPN049730 UNKNOWN 14026704625243

    Patients

    Seq Age Sex Outcome Treatment
    1