BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD E-Z SCRUB

    MDR report key: 16416395 · Received February 22, 2023

    Report

    Report Number
    16416395
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 14, 2023
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    GEC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENTIRE BOX OF BD E-Z SCRUB¿ PREOPERATIVE SURGICAL SCRUB BRUSHES HAD PACKAGING DEFECTIVE. THE PACKAGING HAS A PERMEABLE PERFORATION DOWN THE LENGTH OF IT THAT CAUSED THE BRUSHES TO BE EXPOSED TO CONTAMINATES AND DRY UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407692 BD E-Z SCRUB BRUSH, SCRUB, OPERATING-ROOM GEC CAREFUSION 2200, INC. 2200430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown