BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SOURCE SECONDARY TUBING WITH ATTACHED CLOSED MALE ADAPTO

    MDR report key: 1007041 · Received March 3, 2008

    Report

    Report Number
    MW5005774
    Event Type
    Injury
    Date Received
    March 3, 2008
    Date of Event
    January 2, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ICU/SPIROS/SET SOURCE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A LEUCOVOR, IV INFUSION THE PT'S WIFE NOTICED A COUPLE OF DROPS OF THE SOLUTION LEAKING OUTSIDE OF THE CLOSED MALE ADAPTOR CONNECTION. RN IMMEDIATELY TERMINATED THE INFUSION AND PROPERLY DISPOSED OF THE HAZARDOUS CHEMO-THERAPY WASTE. OVER THE NEXT SEVERAL WEEKS BOTH OM CG PHARMACY AND NURSING NOTICED NUMEROUS ADDITIONAL DEFECTIVE SETS DURING THE COMPOUNDING, CHECKING AND BACK PRIMING PROCESS. THESE PRODUCTS DID NOT REACH THE PT AND WERE SAVED FOR ANALYSIS. SIX (6) DEFECTIVE PRODUCT SAMPLES WERE GIVEN TO THE CO REP IN 2008 OMC PHARMACY AND 35 OF PERSONELL WERE NOTIFIED AS WELL AS OMC MATERIAL MAF. AN INTERNAL SRM REPORT WAS FILED AND WE HAVE SUSPENDED THE USE OF THIS LOT NUMBER ON A PERMANENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET SOURCE SECONDARY TUBING WITH ATTACHED CLOSED MALE ADAPTO ICU MEDICAL DEVICE CAT # Z7020 FPA ICU/SPIROS/SET SOURCE Z-7020 54-824-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention