BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEMOLOCK - BAG SPIKE WITH ADDITIVE PORT (CL-13)

    MDR report key: 8982530 · Received September 9, 2019

    Report

    Report Number
    MW5089671
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CL-13 CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT FROM ICU MEDICAL, INC. MFR DEFECTS WERE SYRINGE ADAPTER FLANGE ON THE BAG SPIKE WAS TURNED IN AND NOT TURNED OUT TO ACCEPT SYRINGE ADAPTER FROM ICU MEDICAL TO MAINTAIN A CLOSED SYSTEM WHILE COMPOUNDING HAZARDOUS DRUG, CARFILZOMIB. UPON PHARMACY TECH ATTEMPTING TO CONNECT THE BAG SPIKE ADAPTOR TO THE SYRINGE ADAPTER, THE END OF THE ENTIRE SYRINGE BROKE APART AS IT WAS UNABLE TO BE, "CLICKED" TOGETHER FOR A CLOSED SYSTEM. THIS RESULTED IN A PT TREATMENT DELAY, PHARMACY STAFF EXPOSURE TO HAZARDOUS DRUG, AND LOSS OF EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772231 CHEMOLOCK - BAG SPIKE WITH ADDITIVE PORT (CL-13) CLOSED ANTINEOPLASTIC AND DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL, INC. CL-13 3601318

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention