BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CENTRAL LINE CATHETER

    MDR report key: 19776372 · Received July 17, 2024

    Report

    Report Number
    MW5157374
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 15, 2024
    Manufacturer
    MEDCOMP / MEDICAL COMPONENTS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SHEATH/COVERING OVER THE GUIDE WIRE BECAME UNRAVELED OUTSIDE OF THE PATIENT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220989 ARROW CENTRAL LINE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ MEDCOMP / MEDICAL COMPONENTS INC. ASK-42703-SHUF2 33F23L0686

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male