BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT® SA CULTURE BOTTLE

    MDR report key: 7139416 · Received December 21, 2017

    Report

    Report Number
    3002769706-2017-00409
    Event Type
    Injury
    Date Received
    December 21, 2017
    Report Date
    February 16, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026055806
    PMA / PMN Number
    K020931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE INVESTIGATION EXAMINED THE MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING AND ALL RESULTS WERE WITHIN SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE FINISHED GOODS. THE ROOT CAUSE FOR THE COLLAPSED BOTTLE WAS NOT DETERMINED. AT THIS TIME, WE CONSIDER THIS A MANUFACTURING VARIANCE AND WILL CONTINUE TO MONITOR THIS ISSUE. THE INSTRUCTIONS FOR USE STATE PRIOR TO USE, VISUALLY INSPECT ALL BACT/ALERT® BOTTLES. BOTTLES EXHIBITING EVIDENCE OF DAMAGE OR DETERIORATION SHOULD BE DISCARDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DEFORMED BACT/ALERT® SA CULTURE BOTTLE. THE CUSTOMER REPORTED THAT ONE OF THE DEFORMED BOTTLES WAS IDENTIFIED AFTER INOCULATION. THE DEFORMATION IS ON THE SIDE OF THE BOTTLE AND A CRACK WAS ALSO OBSERVED. THE CUSTOMER REPORTED HAVING TO COLLECT BLOOD FROM THE PATIENT AGAIN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917607 BACT/ALERT® SA CULTURE BOTTLE BACT/ALERT® SA CULTURE BOTTLE MDB BIOMERIEUX INC. 1048669 03573026055806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention