BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER TUBING

    MDR report key: 16657283 · Received March 30, 2023

    Report

    Report Number
    MW5116176
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 28, 2023
    Report Date
    March 28, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412676647
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING COMPOUNDING OF CHEMOTHERAPY, THE LUER LOCK SCREW AT THE END OF THE TUBING WAS NOT SCREWING ONTO THE FEMALE EQUASHIELD ADAPTER, ALMOST AS IF THE THREADING WAS STRIPPED OR NOT THERE. THREADING WAS INTACT, HOWEVER, THE SCREW WOULD FALL AFTER LETTING GO. WE CHANGED TO A DIFFERENT ADAPTER AND THE SCREW WAS STILL NOT CATCHING ONTO IT. WE SWITCHED TUBING AND THE SCREW WAS SECURED. WITHOUT THIS SCREW BEING SECURED WITH THE CLOSED SYSTEM TRANSFER DEVICE, THERE WAS A POSSIBILITY OF CHEMOTHERAPY LEAKAGE. PRODUCT DID NOT REACH PATIENT - WAS CAUGHT BY THE COMPOUNDING PHARMACIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529922 BAXTER TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2R8538 (10)DR21L15048 00085412676647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FEMALE LEUR LOCK CONNECTOR