BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER HEALTHCARE CORP

    MDR report key: 288987 · Received August 1, 2000

    Report

    Report Number
    MW1019516
    Event Type
    Malfunction
    Date Received
    August 1, 2000
    Date of Event
    July 21, 2000
    Report Date
    July 31, 2000
    Manufacturer
    BAXTER
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTS INJECTION CAP HAS STARTED LEAKING SINCE STARTED USING THE NEW BLUNT CANNULAS. WAS CHANGING ONCE/WEEK. NOW CHANGING 2X WEEK. CONCERN RE: INJECTION CAP NOT BEING INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER HEALTHCARE CORP INTERLINK INJECTION SITE FOZ BAXTER * SI343434R

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other (BD)| 10CC BLUNT PLASTIC CANNULA SYRINGE REORDER# 303348