BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 24332477 · Received February 13, 2026

    Report

    Report Number
    24332477
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 13, 2026
    Report Date
    January 29, 2026
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    NO HARM TO PATIENT. PT CONNECTED TO 46 HOUR 5FU INFUSION ON HOME INFUSION CADD PUMP ON [REDACTED]. PT AWOKE ON [REDACTED]-THE NEXT DAY, IN THE MORNING AND CALLED ON CALL PROVIDER TO REPORT DISCONNECTION AND LEAKING OF TUBING AND 5FU. PT TO CLINIC [REDACTED]-2 DAYS AFTER GOING HOME WITH PUMP FOR ASSESSMENT AND D/C [DISCONTINUATION]. UPON EXAMINING TUBING AND CSTD [CLOSED-SYSTEM TRANSFER DEVICE], FOUND TO HAVE LEAK IN TUBING AT SITE OF CARTRIDGE INSERTION INTO CADD PUMP. NO CHEMO LEAKED FROM CSTD DEVICE WHEN ASSESSING EQUIPMENT AND TUBING. CADD INFUSION PUMP TUBING PROVIDED FROM PHARMACY. UNABLE TO PINPOINT WHICH LOT # USED FOR PARTICULAR PATIENT BUT LOT #S STORED IN PHARMACY ARE 3 LOT #'S IN STOCK - 6093386 EXP 02/01/30, 6038621 11/19/29 AND 6068924 EXP 11/19/29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392842 SET, ADMINISTRATION, INTRAVASCULAR FPA 6093386, 6038621, 6068924

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other