BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL CHOCOLATE II AGAR, 100 PLATES

    MDR report key: 17299033 · Received July 11, 2023

    Report

    Report Number
    1119779-2023-00760
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTY
    PMA / PMN Number
    PREAMENDMENT
    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.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES, D9: RETURNED TO MANUFACTURER ON: 2023-07-11. H.6. INVESTIGATION SUMMARY: MATERIAL #: 251267; LOT/BATCH #: 3101725. BD RECEIVED CUSTOMER RETURNED SAMPLES AND PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR BIOLOGICAL CONTAMINATION WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED AND NO ISSUES WERE IDENTIFIED. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR CONTAMINATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL CHOCOLATE II AGAR, 100 PLATES THERE WAS CONTAMINATION FOUND ON THE MEDIA. THIRTY PLATES WERE AFFECTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, SIGNS OF WHITISH MATTER WERE FOUND ON THE SURFACE OF THE MEDIA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL CHOCOLATE II AGAR, 100 PLATES THERE WAS CONTAMINATION FOUND ON THE MEDIA. THIRTY PLATES WERE AFFECTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, SIGNS OF WHITISH MATTER WERE FOUND ON THE SURFACE OF THE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569391 BD BBL CHOCOLATE II AGAR, 100 PLATES CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON DICKINSON & CO. (SPARKS) 3101725

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown