BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYREX

    MDR report key: 222890 · Received May 11, 1999

    Report

    Report Number
    MW1016286
    Event Type
    Malfunction
    Date Received
    May 11, 1999
    Date of Event
    April 23, 1999
    Report Date
    May 11, 1999
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHITE PRECIPITATES NOTED IN SALINE FLUSH SOLUTION. IF SHAKEN, PRECIPITATES ADMIX AND IF ALLOWED TO SIT AFTER SHAKING, THEY SETTLE OUT AGAIN. THIS IS THE SECOND BATCH FROM THE SAME CO THAT FACILITY HAS HAD PROBLEMS WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYREX 0.9% 5 ML SALINE FLUSH FMF EXCELSIOR MEDICAL CORP. NA 02_26_2001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MULTIMED LINES AND SALINE LOCKS.