BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINER

    MDR report key: 13176559 · Received January 5, 2022

    Report

    Report Number
    MW5106480
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 4, 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] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): THE SPECIMEN CONTAINER IS LEAKING THE 0.85% SALINE SOLUTION AFTER SWAB HAS BEEN PLACED AND IT IS SENT FOR PROCESSING. OVER 100 PLUS PATIENTS HAVE REQUIRED RETESTING FOR COVID DUE TO THE LEAKING OF THIS PRODUCT. PACKAGES HAVE BEEN FOUND WITH THE SPECIMEN CONTAINER NOT HAVING ENOUGH SALINE IN IT MOISTURE IN THE BAG, AS WELL AS THE SPECIMENS BEING REJECTED BY THE PROCESSING LAB DUE TO MOISTURE AND VISIBLE LIQUID OUTSIDE OF THE SPECIMEN CONTAINER. THE ITEMS IN THE KIT ARE PREPACKAGED BY THE COMPANY FOR USE BY THE INSTITUTION. THE SPECIMEN CONTAINER WITH THE MEDIUM IS WHAT WE ARE HAVING ISSUES WITH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477160 BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINER CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG AZER SCIENTIFIC, INC 26533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown