BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SET

    MDR report key: 325492 · Received March 29, 2001

    Report

    Report Number
    MW1021562
    Event Type
    Malfunction
    Date Received
    March 29, 2001
    Report Date
    March 29, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT PROBLEM THAT HAS POSSIBILITY TO CAUSE DEATH TO PT. PRODUCT IS MFG BY BAXTER HEALTHCARE CORP. PRODUCT IS BURETROL SOLUTION SET, ITEM NUMBERS 2C7546S MALE LUER SLIP ADAPTER, AND ITEM NUMBER 2C7566S MALER LUER LOCK ADAPTER. WHEN BEING USED, PRODUCT PULLS AIR AND EXCESSIVE FLUID STREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14334 BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SET BURETROL SOLUTION SET-INTERLOCK SYSTEM FPA BAXTER HEALTHCARE CORP 2C7546S *
    14335 BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SET BURETROL SOLUTION SET-INTERLOCK SYSTEM FPA BAXTER HEALTHCARE CORP 2C7566S *

    Patients

    Seq Age Sex Outcome Treatment
    1 *