BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC

    MDR report key: 20075132 · Received August 27, 2024

    Report

    Report Number
    20075132
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 14, 2024
    Report Date
    August 21, 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

    WHILE PLACING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, I ATTEMPTED TO BREAK THE MODIFIED SELDINGER INTRODUCER. INSTEAD OF SPLITTING DOWN THE MIDDLE ALLOWING ME TO REMOVE THE INTRODUCER, ONE BLUE WING BROKE OFF COMPLETELY. LEAVING THE REMAINDER OF THE PLASTIC CATHETER AROUND THE LINE. MUCH EFFORT WAS GIVEN TO SPLIT THE INTRODUCER. IT TOOK OVER 20 MINUTES AND I WAS VERY CONCERNED ABOUT DISLODGING THE PICC OR HARMING IT IN THE PROCESS. EVENTUALLY IT SPLIT AND I WAS ABLE TO PROCEED WITH THE LINE PLACEMENT. THIS WAS ON A MICRO PREMIE WITH VERY LIMITED VEINS. THIS WAS INCREDIBLE STRESSFUL ON A VERY DELICATE/FRAGILE PATIENT. MANUFACTURER RESPONSE FOR INTRODUCER, SYRINGE NEEDLE, NEOMAGIC (PER SITE REPORTER). ISSUES ONGOING WITH THIS PRODUCT - STILL NO RESOLVE ON INVESTIGATIONS. WE HAVE SENT SAMPLES AND AWAIT THEIR CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24584 NEOMAGIC INTRODUCER, SYRINGE NEEDLE KZH NEO MEDICAL INC. 1958-004 1069

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Male