BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTOR® SECONDARY IV ADMINISTRATION SET WITH ULTRASITE® INJ. SITE

    MDR report key: 7510793 · Received May 14, 2018

    Report

    Report Number
    7510793
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 27, 2018
    Manufacturer
    TEVA PHARMACEUTICAL INDUSTRIES LIMITED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS TUBING WAS PRIMED WITH SALINE BY PHARMACY TECH AND SPIKED INTO BLEOMYCIN CHEMOTHERAPY FOR ADMINISTRATION. THIS RN HUNG DRUG, ATTACHED TO PRIMARY TUBING, UNCLAMPED AND INITIATED INFUSION. THE LIQUID IMMEDIATELY STARTED LEAKING/DRIPPING OUT A FAULTY PART OF THIS TUBING. THE SITE OF LEAKING WAS WHERE THE WHITE Y-SITE CONNECTOR MET THE PURPLE/CLEAR PLASTIC PIECE THAT CONNECTS THE Y-SITE TO THE TUBING. LUCKILY IT WAS LIKELY SALINE DRIPPING OUT AS THE LINE IS PRIMED WITH SALINE FOR SAFETY, BUT HAD THIS NOT BEEN NOTICED IMMEDIATELY BY THIS RN IT WOULD HAVE RESULTED IN A CHEMO SPILL, NURSE AND PATIENT EXPOSURE, WASTED COSTLY DRUG AND INCORRECT PATIENT DOSE. INFUSION WAS IMMEDIATELY STOPPED AND RETURNED TO PHARMACY TO CHANGE OUT TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353277 TEVADAPTOR® SECONDARY IV ADMINISTRATION SET WITH ULTRASITE® INJ. SITE SET, ADMINISTRATION, INTRAVASCULAR FPA TEVA PHARMACEUTICAL INDUSTRIES LIMITED P-7972-3 UA0018A

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.