BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN MEDICAL INC.

    MDR report key: 13042903 · Received December 20, 2021

    Report

    Report Number
    13042903
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BRAUN
    Product Code
    PTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I ACCESSED THE ABOVE PATIENT'S PORT WITH THE NEW 20G PORT NEEDLES. WHEN I DREW BACK, BLOOD IMMEDIATELY BEGAN SEEPING AROUND THE NEEDLE AND RUNNING DOWN THE PATIENT¿S CHEST. IT REQUIRED ME TO REMOVE THE NEEDLE AND APPLY LIGHT PRESSURE FOR 30 SECONDS AND RE-ACCESS PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941169 B. BRAUN MEDICAL INC. NON-CORING (HUBER) NEEDLE PTI BRAUN 21B10G8671

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Male