BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC

    MDR report key: 20075362 · Received August 27, 2024

    Report

    Report Number
    20075362
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 14, 2024
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I USED A NEOMAGIC MODIFIED SELDINGER INTRODUCER KIT LOT # 1068 TO PLACE A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IN THE PATIENT. AFTER OBTAINING THE X-RAY AND VERIFYING PLACEMENT, WHEN TRYING TO REMOVE THE INTRODUCER THE RIGHT SIDE WING BROKE OFF WITHOUT TEARING THE SHEATH. AFTER 45 MINUTES OF TRYING WAS ABLE TO REMOVE THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23607 NEOMAGIC INTRODUCER, SYRINGE NEEDLE KZH NEO MEDICAL INC. 1958-004 1068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other