BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUFFERED SALINE SOLUTION 0.85%

    MDR report key: 13205482 · Received January 7, 2022

    Report

    Report Number
    MW5106523
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    January 4, 2022
    Report Date
    January 5, 2022
    Manufacturer
    AZER SCIENTIFIC INC.
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [STERILE BUFFERED SALINE SPECIMEN CONTAINER] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): THE CONTAINERS WITH THE STERILE BUFFERED SALINE IN IT WAS FOUND WITH THE CAP NOT ON COMPLETELY AND THE SALINE SOLUTION HAD LEAKED OUT OF THE CONTAINER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476076 BUFFERED SALINE SOLUTION 0.85% CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG AZER SCIENTIFIC INC. ES45044 26858

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown