BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CJ4303, 8C290

    MDR report key: 294013 · Received August 31, 2000

    Report

    Report Number
    MW1019821
    Event Type
    Malfunction
    Date Received
    August 31, 2000
    Date of Event
    August 23, 2000
    Report Date
    August 23, 2000
    Manufacturer
    DELTEC/SIMS DELTEC, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRIMING VOLUME DESCRIBED ON PACKAGE LABEL SEEMS INACCURATE, A) LOW ABSORPTION TUBING 8C 290 IV ADMINISTRATION SET LABELED APPROX 16ML, RPTR'S EXPERIENCE 29ML. B) BURETTE CJ4303 IV ADMINISTRATION SET LABELED APPROX 12.5ML, RPTR'S EXPERIENCE 20ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CJ4303, 8C290 IV ADMINISTRATION SETS FPA DELTEC/SIMS DELTEC, INC CJ4303, 8C290 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other