BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALINE FLUSH INJECTION

    MDR report key: 448972 · Received March 12, 2003

    Report

    Report Number
    MW4003476
    Event Type
    Malfunction
    Date Received
    March 12, 2003
    Manufacturer
    EXCELSIOR MEDICAL CORP
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DEFECT: CLOUDY. OBVIOUS CONTAMINANT OF 5ML 0.9% SODIUM CHLORIDE FLUSH SYRINGE. SYRINGE APPEARED "MURKY" WITH BROWN SUBSTANCE NEAR PLUNGER SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FLUSH INJECTION SODIUM CHLORIDE FOZ EXCELSIOR MEDICAL CORP 0.9%, 5 X 100 BOX 12 12 04

    Patients

    Seq Age Sex Outcome Treatment
    1 *