BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOW PLASTICIZER PVC ADMINISTRATION SET

    MDR report key: 516277 · Received January 20, 2004

    Report

    Report Number
    6000001-2004-00049
    Event Type
    Other
    Date Received
    January 20, 2004
    Date of Event
    October 1, 2003
    Report Date
    October 14, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS SETS ARE LEAKING CHEMO DURING PT USE AFTER RELEASING THE ROLLER CLAMP. BOTH NURSES AND PTS HAVE BEEN EXPOSED TO CHEMO, HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED. REPORTER STATES EXPOSED AREAS WERE CLEANSED AND CHEMO WAS CLEANED WITH A SPILL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PLASTICIZER PVC ADMINISTRATION SET IV ADMINISTRATION SET FPA BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN