BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR TUBING BX 100

    MDR report key: 12321399 · Received August 13, 2021

    Report

    Report Number
    3014246639-2021-00002
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Report Date
    July 21, 2021
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    DXT
    PMA / PMN Number
    K882329
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2021. THE CUSTOMER REPORTED THAT REGARDING THE SPIRAL CONNECTOR HOSE BEING NARROWER, IT WOULD BE IMPACTING THE CONTRAST INJECTION PRESSURE, INFUSING A LARGER VOLUME THAN RECOMMENDED. REPORTER STATES THAT PATIENT WAS CONNECTED AT THE TIME AND THAT HARM AND CLINICAL CONSEQUENCE OCCURRED, WITH THE PATIENT EXPERIENCING OVERDOSE AND EXTRAVASATION. HENETIX WAS THE REPORTED CONTRAST AGENT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216298 CONNECTOR TUBING BX 100 CONNECTOR TUBING BX 100 DXT CATHETER RESEARCH, INC. 601195 C1469CR

    Patients

    Seq Age Sex Outcome Treatment
    1