BEUDAMED
    FDA Adverse Event Summary report: N

    VERSATREK REDOX 1 EZ DRAW 40ML W/STIR BAR

    MDR report key: 5180451 · Received October 21, 2015

    Report

    Report Number
    1924669-2015-00001
    Date Received
    October 21, 2015
    Date of Event
    September 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    REMEL, INC.
    Product Code
    MDB
    PMA / PMN Number
    K032306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INJURY WAS TO A USER FACILITY EMPLOYEE, NOT TO A PT. USER FACILITY DID NOT REPOT INCIDENT TO MFR (REMEL, INC.) BUT GAVE LIMITED DETAILS. INCIDENT WAS REPORTED BY USER FACILITY TO REMEL, INC., WITH ONLY LIMITED INFO, AS PROVIDED BY THE MICROBIOLOGY LAB WORKER (B)(6) AND THE MICROBIOLOGY SUPERVISOR (B)(6). USER FACILITY (B)(6) WAS CONTACTED AGAIN ON (B)(6) 2015 BY PHONE FOR ADD'L INFO. (B)(6) INDICATED THE INJURED EMPLOYEE DOES NOT WORK FOR MICROBIOLOGY, WORKS IN PROCESSING UNDER SUPERVISOR (B)(6); NO OTHER INFO PROVIDED. USER FACILITY (B)(6) WAS CONTACTED BY PHONE ON (B)(6) 2015; MESSAGE LEFT INDICATING REMEL, INC., WANTS MORE INFO TO USE IN OUR MDR.

    Description of Event or Problem · 1

    PROCESSING TECH NOTICED A BOTTLE "LEAK ALERT" CODE ON VERSATREK INSTRUMENT AND WAS REMOVING THE SINGLE VERSATREK REDOX 1 BLOOD CULTURE BOTTLE FROM THE INSTRUMENT WHEN IT BROKE AT THE BASE OF THE NECK. THE PROCESSING TECH SUSTAINED A CUT TO THE HAND DUE TO THE BROKEN GLASS AND, SINCE THE BOTTLE HAD BEEN INOCULATED WITH BLOOD, THE PROCESSING TECH WENT TO THE ER TO RECEIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697313 VERSATREK REDOX 1 EZ DRAW 40ML W/STIR BAR AEROBIC BLOOD CULTURE BOTTLE MDB REMEL, INC. 695897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other