BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC

    MDR report key: 20075291 · Received August 27, 2024

    Report

    Report Number
    20075291
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 8, 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

    PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED USING A PEEL-AWAY MODIFIED SELDINGER INTRODUCER. WHEN TRYING TO PEEL AWAY THE INTRODUCER, ONE OF THE WINGS BROKE OFF LEAVING THE PLASTIC SHEATH ATTACHED TO THE LINE. IT WAS VERY DIFFICULT TO REMOVE THE SHEATH WITHOUT DISLODGING THE LINE ON THIS 800 GRAM BABY, AND IT HAD TO BE MANUALLY PEELED OFF USING SHARP TWEEZERS THAT RISKED DAMAGING THE LINE. THIS HAS BEEN ESCALATED TO OUR PRODUCTS/MATERIALS TEAM & DEFECTIVE PRODUCTS, AS WELL AS THE COMPANY. THIS IS OUR FIFTH MODIFIED SELDINGER INTRODUCER THAT HAS BROKEN DURING USE. THIS IS THE FIRST ONE THAT HAS BROKEN FROM LOT NUMBER 1068. MANUFACTURER RESPONSE FOR INTRODUCER, SYRINGE NEEDLE, NEOMAGIC (PER SITE REPORTER) NEO MEDICAL HAS ISSUED US AN RETURN MERCHANDISE AUTHORIZATION (RMA) FORM AS WELL AS A DATA COLLECTION FORM. WILL WORK WITH CLINICAL CAREGIVERS TO GET THIS COMPLETED AND RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25474 NEOMAGIC INTRODUCER, SYRINGE NEEDLE KZH NEO MEDICAL INC. 1958-004

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Male Other