BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER BEBACK CROSSING 603 2.9 F 120 CM

    MDR report key: 19511399 · Received June 10, 2024

    Report

    Report Number
    MW5156105
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BENTLEY INNOMED GMBH
    Product Code
    PDU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER PLACED CATHETER AND REMOVING NEEDLE, PROVIDER WAS UNABLE TO RETRACT NEEDLE FOR SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864004 CATHETER BEBACK CROSSING 603 2.9 F 120 CM CATHETER FOR CROSSING TOTAL OCCLUSIONS PDU BENTLEY INNOMED GMBH FFP603L035

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention