BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME

    MDR report key: 24567844 · Received March 11, 2026

    Report

    Report Number
    24567844
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 4, 2026
    Manufacturer
    MOZARC MEDICAL US LLC
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WENT TO THE INTERVENTIONAL RADIOLOGY SUITE TO HAVE A HEMODIALYSIS CATHETER PLACED ON [REDACTED]. THE CATHETER WAS PLACED SUCCESSFULLY. THE RED AND BLUE CAPS WERE PLACED ON TO THE END OF THE PORTS BY THE PROCEDURALIST. INTERVENTIONAL RADIOLOGY NURSING CONFIRMED THAT THE CAPS WERE IN PLACE. THIS WAS DOCUMENTED IN BOTH THE CENTRAL LINE CHECKLIST AND THE PROCEDURE REPORT. ON [REDACTED]-THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO THE HEMODIALYSIS UNIT TO HAVE A DIALYSIS SESSION. IT WAS FOUND THAT THE WHITE CAP HAD COME OFF OF THE RED CAP AT THE END OF THE LUMEN. THE LINE WAS THEN DEEMED TO BE POTENTIALLY CONTAMINATED AND UNABLE TO BE USED. THE PATIENT THEN RETURNED TO THE FLOOR, UNABLE TO COMPLETE THEIR DIALYSIS SESSION. THE PATIENT REQUIRED A SECOND PROCEDURE TO HAVE THE LINE REPLACED ON [REDACTED]-TWO DAYS AFTER THE FIRST HEMODIALYSIS CATHETER WAS PLACED. THE ORIGINAL INTENDED PROCEDURE WAS FOR THE PATIENT TO HAVE A HEMODIALYSIS LINE PLACED AND TO RECEIVE A RUN OF HEMODIALYSIS. THIS EVENT CAUSED THE PATIENT TO MISS A DIALYSIS SESSION AND REQUIRED A SECOND PROCEDURE TO HAVE A NEW LINE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629233 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED MSD MOZARC MEDICAL US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other