BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOMAGIC

    MDR report key: 19191276 · Received April 26, 2024

    Report

    Report Number
    19191276
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 2, 2024
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    KZH
    Adverse Event
    Yes
    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

    MODIFIED SELDINGER DILATOR DIDN'T PEEL PROPERLY DURING EXTENDED DWELL PLACEMENT. BLUE WINGS BROKE OFF BUT PLASTIC STILL INSIDE VEIN. HAD TO REMOVE LINE IN ORDER TO REMOVE THE BROKEN PLASTIC PIECE. RESULTED IN MULTIPLE ADDITIONAL ATTEMPTS TO ACCESS VEIN FOR NEW EXTENDED DWELL PLACEMENT. LOT #1067. MANUFACTURER RESPONSE FOR INTRODUCER, SYRINGE NEEDLE, NEOMAGIC (PER SITE REPORTER). USER FACILITY EMAILED MANUFACTURER. NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866064 NEOMAGIC INTRODUCER, SYRINGE NEEDLE KZH NEO MEDICAL INC. 1958-004 1067

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female Other