BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 16410624 · Received February 21, 2023

    Report

    Report Number
    1319211-2023-00008
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 22, 2023
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    PMA / PMN Number
    K101843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT EVENT WAS INCORRECTLY SUBMITTED UNDER THE INCORRECT REGISTRATION NUMBER. THE REPORT SUBMITTED WAS 1319211-2023-0008. IN ORDER TO CLOSE OUT THIS RECORD, THIS REPORT IS BEING SUBMITTED. THE COMPLAINT EVENT WILL BE REPORTED UNDER THE CORRECT REGISTRATION NUMBER REFERENCE 1317056-2023-00025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ISSUE WITH THEIR DURAMAX BIOFLO DIALYSIS CATHETER. IT WAS RECENTLY NOTICED THAT THE PATIENT HAD "COATINGS" OF THE CATHETER MATERIAL ON THE THIGH FROM THE CATHETER. THE MATERIAL HAS NOT RUBBED OFF ON THE PATIENT MORE THAN ONCE. THE PATIENT WAS DIALYSING WITH FRAGMIN 7500 E/HD, AND THE LEGS OF THE CATHETER WERE PLUGGED WITH DURA LOCK. THE CATHETER WAS LOCKED AT 30% CITRATE. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DURAMAX. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319691 DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD ANGIODYNAMICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male