BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEVER LOCK ADAPTOR

    MDR report key: 172403 · Received June 10, 1998

    Report

    Report Number
    172403
    Event Type
    Other
    Date Received
    June 10, 1998
    Date of Event
    May 20, 1998
    Report Date
    June 4, 1998
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTRAVENOUS CHEMOTHERAPY INITIATED ON PT (05/20/1998) THROUGH A PERIPHERALLY INSERTED CENTRAL CATHETER LINE PRIOR TO DISCHARGE (05/21/1998). HOME HEALTH NURSE IDENTIFIED THE INFUSION WAS LEAKING WHEN SHE SAW THE CLIENT ON 05/22/1998. SHE IMMEDIATELY NOTIFIED FACILITY AND CLEANED UP THE SPILL PER PROTOCOL USING A CHEMO SPILL KIT. THE HUSBAND STATED HE HAD NOTED BLOOD BACKING UP IN PERIPHERALLY INSERTED CENTRAL CATHETER LINE AT APPROXIMATELY 1630 ON 05/21/1998 AFTER BRINGING HIS WIFE HOME. IT WAS DETERMINED THAT APPROXIMATELY 44 ML OF CHEMO AGENT HAD LEAKED OUT (2 ML/HOUR X 22 HOURS). WHEN THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE WAS ATTACHED TO THE INTRAVENOUS PUMP TUBING, AN INCORRECT CONNECTOR PIECE WAS USED. THIS IS THE SITE WHERE THE LEAK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVER LOCK ADAPTOR IV TUBING CONNECTOR FPA BECTON DICKINSON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other