BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 15416858 · Received September 14, 2022

    Report

    Report Number
    3012307300-2022-19053
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Report Date
    September 14, 2022
    Manufacturer
    NULL
    Product Code
    NXA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE ADDRESS IS UNKNOWN. CATALOG NUMBER IS UNKNOWN. UDI INFORMATION IS UNKNOWN. PREMARKET (510K) NUMBER IS UNKNOWN. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE KIT CONTAINED PURPLE TRACHEOSTOMY INDUCER THAT DOES NOT CORRECTLY FIT OVER THE GUIDING CATHETER. IT WAS NOT ABLE TO THREAD ALL THE WAY TO THE SAFETY STOP MARK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673034 PORTEX TRACHEOTOMY CARE KIT NXA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown