BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK

    MDR report key: 16538281 · Received March 14, 2023

    Report

    Report Number
    1119779-2023-00279
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    NA
    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 SUMMARY: MATERIAL #: 251181. LOT/BATCH #: 2325441. BD RECEIVED SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED. THE RETENTION SAMPLES COULD NOT BE REVIEWED AS THE BATCH WAS ALREADY EXPIRED. BASED ON A REVIEW OF THE BATCH 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 NOT CONFIRMED FOR THE INDICATED FAILURE MODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK A FUZZY APPEARANCE WAS FOUND IN MEDIA BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER. THE CUSTOMER FOUND MATTER WITH A FUZZY APPEARANCE IN THE MEDIA BEFORE USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK A FUZZY APPEARANCE WAS FOUND IN MEDIA BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER. THE CUSTOMER FOUND MATTER WITH A FUZZY APPEARANCE IN THE MEDIA BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914717 BD BBL¿ SALMONELLA SHIGELLA AGAR PLATE 20PK CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 2325441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown