BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBER PAC NEEDLE WITH TUBING, 20 G, 1"

    MDR report key: 11924 · Received March 10, 1994

    Report

    Report Number
    MW1001025
    Event Type
    Injury
    Date Received
    March 10, 1994
    Date of Event
    February 9, 1994
    Report Date
    February 15, 1994
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CALLED RPTR'S OFFICE ON 2/8/94 TO REPORT 5-FU LEAKING AROUND NEEDLE SITE. PT NOTED SMALL AMOUNT OF DRIED WHITE CRYSTALS AROUND NEEDLE SITE. THE NEEDLE INTACT. FLUSHED WITHOUT PROBS OR LEAKING AND POSITIVE BLOOD RETURN. PT CALLED RN-ON-CALL ON 2/9/94 PM TO REPORT THAT SHE NOTED SOME LEAKAGE AGAIN AT NEEDLE SITE. CRYSTALS NOTED NEAR NEEDLE SITE. WHEN DRESSING TAKEN OFF IT WAS NOTED THAT SILVER NEEDLE PORTION WAS MOVEABLE IN AND OUT OF YELLOW WINGED PORTION OF THE NEEDLE. NEEDLE REMOVED AND OPPOSITE SIDE ACCESSED WITH NEW NEEDLE AND 5-FU INFUSION CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUBER PAC NEEDLE WITH TUBING, 20 G, 1" FOZ CHURCHILL MEDICAL SYSTEMS, INC. MBY-2010 3G28A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PHARMACIA CADD PLUS PUMP WITH 30 " EXTENSION TUBE