BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC

    MDR report key: 19267064 · Received May 8, 2024

    Report

    Report Number
    19267064
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 25, 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

    DURING A DIFFICULT ULTRASOUND PICC PLACEMENT, THE DILATOR SHEATH BROKE WHEN TRYING TO PEEL IT APART. NURSE PLACED THE LINE, I (M.D.) WAS ASSISTING. ONE OF THE BLUE WINGS POPPED COMPLETELY OFF THE CLEAR PLASTIC SHEATH. MANY ATTEMPTS WERE MADE TO PEEL THE SHEATH, ALL WERE UNSUCCESSFUL. DUE TO THE DIFFICULTLY WE HAD IN SUCCESSFULLY THREADING A PICC LINE, THE DECISION WAS MADE TO LEAVE THE PLASTIC SHEATH OVER THE LINE (BUT OUTSIDE OF THE PATIENT) THE RISK OF NOT BEING ABLE TO THREAD A NEW LINE THROUGH A NEW DILATOR WAS FELT TO BE TOO GREAT. THIS IS THE SECOND DILATOR SHEATH THAT HAS BROKEN IN MY PRESENCE IN THE EXACT SAME WAY. THE LOT NUMBER IS 1067. I OPENED ANOTHER DILATOR WITH THE SAME LOT NUMBER AND HAD NO TROUBLE GETTING IT TO PEEL PROPERLY. BETWEEN THAT AND THE FACT THAT MANY PICC LINES HAVE BEEN PLACED WITHOUT INCIDENT FROM THE FIRST OCCURRENCE MAKES ME THINK THAT THE ENTIRE LOT ISN'T AFFECTED. UNSURE WHAT IS CAUSING THE DILATOR TO FAIL OCCASIONALLY. MANUFACTURER RESPONSE FOR INTRODUCER, SYRINGE NEEDLE, NEOMAGIC (PER SITE REPORTER). EMAILED, NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770109 NEOMAGIC INTRODUCER, SYRINGE NEEDLE KZH NEO MEDICAL INC. 1958-004

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male