BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL STERILE PACK PLATED MEDIA

    MDR report key: 11229826 · Received January 26, 2021

    Report

    Report Number
    1119779-2021-00142
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 6, 2021
    Report Date
    September 8, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD REVIEW FOR BATCH 0245449 WAS SATISFACTORY PER INTERNAL PROCEDURES. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE PHYSICAL ATTRIBUTE TESTING. A SAMPLE OF PLATES ARE TESTED FOR PHYSICAL ATTRIBUTES PRIOR TO RELEASE TO ENSURE THAT THEY CONFORM TO PRODUCT SPECIFICATIONS. ALL PHYSICAL ATTRIBUTE TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER BD INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND THE ONLY COMPLAINTS ON BATCH 0245449 WERE TAKEN FROM THIS CUSTOMER FOR DIFFERENT DEFECTS. RETENTION SAMPLES FROM BATCH 0245449 WERE AVAILABLE FOR INSPECTION. FIFTY PLATES IN FIVE UNOPENED SLEEVES FROM BATCH 0245449 WERE INSPECTED AND 0/50 PLATES WERE BROKEN, 0/50 PLATES HAD MISSING OR ILLEGIBLE PLATE PRINT AND 5/50 PLATES HAD ONE SINGLE LARGE BUBBLE ON THE AGAR SURFACE (TIME STAMPS 1435-1437). TWO PHOTOS WERE RECEIVED FOR COMPLAINT (B)(4) FOR MISSING PLATE PRINT. ONE PHOTO SHOWS A SLEEVE LABEL FROM BATCH 0245449 FOR BATCH VERIFICATION. THE OTHER PHOTO SHOWS THE BOTTOM OF AN AGAR PLATE WITHOUT A PLATE PRINT ON THE BOTTOM. NO RETURNS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FOR MISSING PLATE PRINT BY THE PHOTOS PROVIDED. BD WILL CONTINUE TO TREND COMPLAINTS FOR MISSING PLATE PRINT. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO LABEL OR MISSING LABEL INFORMATION WAS FOUND WHILE USING THE BD BBL¿ STERILE PACK PLATED MEDIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME PLATES ARE NOT STAMPED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO LABEL OR MISSING LABEL INFORMATION WAS FOUND WHILE USING THE BD BBL¿ STERILE PACK PLATED MEDIA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME PLATES ARE NOT STAMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129160 BD BBL STERILE PACK PLATED MEDIA NA JSE BECTON, DICKINSON & CO. (SPARKS) 0245449

    Patients

    Seq Age Sex Outcome Treatment
    1