BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP DISCONNECT CAP

    MDR report key: 345045 · Received August 2, 2001

    Report

    Report Number
    1423500-2001-01157
    Event Type
    Injury
    Date Received
    August 2, 2001
    Date of Event
    July 16, 2001
    Report Date
    July 26, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL FOR HOME PT REPORTS PT PRESENTED TO CENTER WITH ABDOMINAL PAIN AND CLOUDY EFFLUENT ON DATE OF EVENT. AN EFFLUENT CULTURE REVEALED GROWTH OF SERRATIA MARCESCENS. PT WAS DIAGNOSED WITH PERITONITIS AND TREATED OUTPATIENT WITH FORTAZ, VANCOMYCIN AND GENTAMICIN IP X 21 DAYS AND COPRO X 14 DAYS. PER RN, PT IS RESPONDING WELL TO TREATMENT. UPON INVESTIGATION OF INCIDENT, RN NOTED THAT PT HAS BEEN REUSING PT'S MINICAPS ON OCCASION. RN STATES SHE DOES NOT FEEL PERITONITIS IS RELATED TO BAXTER PRODUCT, HOWEVER, EXACT SOURCE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34925 MINICAP DISCONNECT CAP MINICAP KDJ BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other