BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 15830062 · Received November 19, 2022

    Report

    Report Number
    1119779-2022-01407
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    August 26, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01407 WAS SENT IN ERROR. THIS IS A DUPLICATE FOR 6202344. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS 1: (B)(4). 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT THERE WAS CONTAMINATED PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CUSTOMER REPORTS CONTAMINATED PLATES - LOT #2166405.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THAT THERE WAS CONTAMINATED PLATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CUSTOMER REPORTS CONTAMINATED PLATES - LOT #2166405.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465980 BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2166405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown