BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBLTM CDC ANAEROBE 5% SHEEP BLOOD AGAR

    MDR report key: 15255510 · Received August 18, 2022

    Report

    Report Number
    1119779-2022-01113
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    August 11, 2022
    Report Date
    August 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    K803025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). 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¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CATALOG NUMBER 221733 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL # 252467, LOT 2130474. WE COULDN'T CONFIRM THIS ISSUE AS A REPORT BECAUSE NO PHOTO OF CONTAMINATION. THE PHOTO DIDN'T SHOW AGAR SURFACE. NO ISSUE IN RETENTION SAMPLES OR DHR. NO TREND. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBLTM CDC ANAEROBE 5% SHEEP BLOOD AGAR, BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO REPORT OF CONFIRMATORY TEST. THERE WERE NO RESULTS REPORTED TO PHYSICIANS AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GET MOLDY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBLTM CDC ANAEROBE 5% SHEEP BLOOD AGAR, BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO REPORT OF CONFIRMATORY TEST. THERE WERE NO RESULTS REPORTED TO PHYSICIANS AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GET MOLDY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847691 BD BBLTM CDC ANAEROBE 5% SHEEP BLOOD AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 2130474

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown