BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE TCBS//TCBS 100 EA

    MDR report key: 12485094 · Received September 16, 2021

    Report

    Report Number
    1119779-2021-01535
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE DEFECT WAS NOT CONFIRMED BECAUSE THERE IS NO PICTURE AND RETURNED SAMPLE. PRODUCT EXPIRED ON JUN 29. BD WILL CONTINUE TO MONITOR FOR TREND. PLEASE EXPLAIN WHY "FAILURE TO INHIBIT" IS SELECTED: GENERALLY SPEAKING, THIS PRODUCT DOESN'T ALLOW TO GROWTH MANY KINDS OF BACTERIA DUE TO INGREDIENTS AND PH VALUE. SINCE IT'S ALREADY EXPIRED, THOSE FEATURES BECAME WEAKER OR WENT DOWN TO INSUFFICIENT LEVEL TO PREVENT GROWING BACTERIA. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 PLATE TCBS//TCBS 100 EA EXPERIENCED BIOLOGICAL CONTAMINATION, AND PHYSICAL DEFORMITIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER¿S REPORT, AIR BUBBLES AND BACTERIAL GROWTH WERE FOUND IN THE MEDIA.

    Additional Manufacturer Narrative · 1

    THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ TCBS AGAR, CATALOG NUMBER 221872 WITH 510K NUMBER EXEMPT. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 PLATE TCBS//TCBS 100 EA EXPERIENCED BIOLOGICAL CONTAMINATION, AND PHYSICAL DEFORMITIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER¿S REPORT, AIR BUBBLES AND BACTERIAL GROWTH WERE FOUND IN THE MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376638 PLATE TCBS//TCBS 100 EA NA JSJ BECTON, DICKINSON & CO. (SPARKS) 1062888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown