BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME

    MDR report key: 21881353 · Received April 22, 2025

    Report

    Report Number
    21881353
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 17, 2025
    Manufacturer
    MOZARC MEDICAL US LLC
    Product Code
    NYU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING A HD [HEMODIALYSIS] CATHETER EXCHANGE IT WAS NOTICED THAT THE STIFFENERS INSIDE THE KIT DID NOT HAVE HOLES THAT ALLOW FOR A WIRE TO PASS THROUGH AND ADVANCE THE CATHETER INTO POSITION. ADDITIONAL SUPPLIES WERE NEEDED SO PROCEDURE WAS COMPLETED WITHOUT ISSUE. SUPPLY WAS A 23CM PALINDROME HEPARIN COATED HEMODIALYSIS CATHETER - REF#: 8888123405P - LOT#: 2412000239.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911371 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED, COATED NYU MOZARC MEDICAL US LLC 8888123405P 2412000239

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male