BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 142252 · Received January 7, 1998

    Report

    Report Number
    1528738-1998-00002
    Event Type
    Death
    Date Received
    January 7, 1998
    Date of Event
    December 6, 1997
    Manufacturer
    ABBOTT LABORATORIES/ROSS PRODUCTS DIVISION
    Product Code
    BSS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE OF THIS REPORT: 1/23/1998. LAB COMMENTS: EVALUATION:(1/6/1998) A KNOT IS NOTED AT BOLUS END, APPROX 8" ABOVE DISTAL TIP IN TUBING STYLET PROTRUDING FROM TUBING APPROX 1" ABOVE BOLUS. UPON VISUAL RECEIPT INSPECTION BLOODY, DARK BROWN SUBSTANCE NOTED OVER ENTIRE LENGTH OF TUBE. NO FUNCTIONAL TUBING PERFORMED DUE TO NATURE OF COMPLAINT. COMMENTS:(1/6/1998) UNABLE TO DETERMINE WHY STYLET PROTRUDING FROM TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BSS ABBOTT LABORATORIES/ROSS PRODUCTS DIVISION 475 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED