BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE SALINE 0.85%

    MDR report key: 18060340 · Received November 1, 2023

    Report

    Report Number
    MW5147678
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 25, 2023
    Manufacturer
    EDGE BIOLOGICALS INC.
    Product Code
    QMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STERILE SALINE ORDERED FOR TESTING. BOX LABELED 0.85% STERILE SALINE, TUBES INSIDE WERE LABELED STERILE WATER. SAMPLES ON 40+ VETERANS AND EMPLOYEES NEEDED TO BE RECOLLECTED DUE TO IMPROPER TRANSPORT MEDIA. THE MANUFACTURER IS EDGE BIOLOGICALS INC. (598 N. 2ND ST, MEMPHIS TN 38105) WWW.EDGEBIOLOGICALS.COM LOT 01223, EXP 01/23/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961580 STERILE SALINE 0.85% TRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE QMC EDGE BIOLOGICALS INC. 01223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other