BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL LINE DRESSING KIT

    MDR report key: 23135567 · Received September 24, 2025

    Report

    Report Number
    MW5176480
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Report Date
    September 19, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THAT THE LAST 3 KITS SHE RECEIVED WERE MISSING THE SILVERLON DISC. PATIENT DID NOT REPORT ANY ADVERSE EVENTS OR MISSED DOSES. NO ADDITIONAL INFORMATION WAS REPORTED. PT CODE: 4582. DEVICE CODES: 2306, 2588. REFERENCE REPORTS MW5176479, MW5176481.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494360 CENTRAL LINE DRESSING KIT DRESSING CHANGE TRAY OXQ MEDLINE INDUSTRIES, LP - SPT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ADEMPAS| AMBRISENTAN| C-TREPROSTINIL 0.05MG/ML