BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC

    MDR report key: 20075130 · Received August 27, 2024

    Report

    Report Number
    20075130
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 10, 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 CENTRAL LINE USING A MODIFIED SELDINGER KIT WITH A PEEL AWAY INTRODUCER, THE INTRODUCER WINGS BROKE OFF INSTEAD OF SPLITTING THE CATHETER SO IT COULD BE PULLED AWAY, LEAVING THE PLASTIC CATHETER ON THE LINE. FORCEPS HAD TO BE USED TO PEEL THE CATHETER OFF THE LINE RISKING LINE DISLODGEMENT AND/OR DAMAGE. MANUFACTURER RESPONSE FOR INTRODUCER, SYRINGE NEEDLE, NEOMAGIC (PER SITE REPORTER) NO RESPONSE ON PRODUCT FAILURE. WORKING ON RETURNING THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24582 NEOMAGIC INTRODUCER, SYRINGE NEEDLE KZH NEO MEDICAL INC. 1958-004 1067

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male