BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT ACCESS NEEDLE

    MDR report key: 20236099 · Received September 17, 2024

    Report

    Report Number
    20236099
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    May 3, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    82869, MODEL 142075- PATIENTS IVAD NEEDLE CRACKED WHILE FLUIDS INFUSING; CRACK WAS NEAR THE CAP END OF THE TUBING. PATIENT WAS DE-ACCESSED AND THEN RE-ACCESSED. RESULTED IN CLOSE TO 45 MINUTES WITHOUT BICARB FLUIDS AND A 15-MINUTE DELAY IN THE LEUCOVORIN DOSE. DEVICE WAS NOT SAVED. 83490, MODEL 672034- NURSE WAS ASSESSING IVAD LINE FOR PATENCY BEFORE INFUSING BLOOD AND LEAK WAS NOTICED IN THE ACCESS LINE. CRACK WAS NOTED ON THE LINE, BELOW THE MICROCLAVE. PORT WAS DEACCESSED DUE TO LINE BREAK AND WAS LATER REACCESSED FOR BLOOD TRANSFUSION. WHEN FLUSHING THE LINE, BLOOD CAME OUT OF A CRACK. IT IS IN THE SAME SPOT AT THE DISTAL END BELOW THE HUB. THIS LINE WAS USED FOR 6 DAYS. THE LINE BROKE ON [REDACTED]. LINE WAS SAVED AND WILL BE RETURNED VIA MAIL TO MFG. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, PORT ACCESS NEEDLE (PER SITE REPORTER). ====================== MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, PORT ACCESS NEEDLE (PER SITE REPORTER) ====================== THEY ARE CHANGING THE PLASTIC FORMULATION TO MAKE IT STRONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532393 PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. 0142075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown