BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN INTRAVENOUS CATHETER

    MDR report key: 19042168 · Received April 3, 2024

    Report

    Report Number
    MW5153534
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 1, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSING WENT TO USE AN IV CATHETER FOR A PATIENT AND NOTICES THE CAP OF THE PRODUCT HAD 3CM BLACK STAIN ON THE CAP. THE DEVICE WAS SEQUESTERED AND NOT NEVER USED ON ANY PATIENT. THIS OCCURRED TO INTROCAN STANDARD 20G IV PRODUCT FROM LOT: 23H25G8301 AND REFERENCE: 4251652-02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374117 INTROCAN INTRAVENOUS CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ B. BRAUN MELSUNGEN AG 23H25G8301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown