BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CL CATHETER EXT SET/LUER ACT. VALVE MLL ADAPTER

    MDR report key: 1000210 · Received February 19, 2008

    Report

    Report Number
    6000001-2008-00058
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    PMA / PMN Number
    K924721
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE SAMPLE WAS MADE; HOWEVER, THE SAMPLE HAS BEEN DISCARDED AND THE LOT NUMBER IS NOT KNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT A FEMALE ADULT PATIENT WHO HAD USED THE CLEARLINK EXTENSION SET DURING AN INITIAL HOSPITALIZATION, WAS DISCHARGED AND RETURNED A FEW DAYS LATER FOR A SECOND ADMISSION BECAUSE THE INTRAVENOUS (IV) SITE HAD BECOME NECROTIC AND REQUIRED CHEMICAL DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL CATHETER EXT SET/LUER ACT. VALVE MLL ADAPTER 80FPA FPA BAXTER HEALTHCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention