BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CHOCOLATE II AGAR 100 EA

    MDR report key: 12334249 · Received August 17, 2021

    Report

    Report Number
    2243072-2021-02087
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 18, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSG
    PMA / PMN Number
    K760459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-19. H6: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FOR INVESTIGATION, THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A RETURNED SAMPLE. THE ISSUE WAS HEMOGLOBIN PARTICLE ON THE BOTTOM OF AGAR BED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED AND THE QC WAS WITHIN ACCEPTABLE LIMITS. NO ISSUES WERE IDENTIFIED IN RETENTION SAMPLE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 300 PLATE CHOCOLATE II AGAR 100 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "THIS IS A REPORT ABOUT CONTAMINATION OF THE CHOCOLATE AGAR."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). 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" MUELLER HINTON CHOCOLATE AGAR CATALOG NUMBER 221802 WHICH HAS 510K NUMBER K760459.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 300 PLATE CHOCOLATE II AGAR 100 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "THIS IS A REPORT ABOUT CONTAMINATION OF THE CHOCOLATE AGAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227738 PLATE CHOCOLATE II AGAR 100 EA CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON 1138278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown