BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOTOMY CARE KIT

    MDR report key: 15491837 · Received September 27, 2022

    Report

    Report Number
    3012307300-2022-20344
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    September 27, 2020
    Report Date
    September 26, 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

    NO INFORMATION HAS BEEN PROVIDED TO DATE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED NO INVESTIGATION OR ROOT CAUSE ANALYSIS COULD BE CONDUCTED GIVEN THAT NO COMPLAINT SAMPLE WAS RETURNED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174302 TRACHEOTOMY CARE KIT NXA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown