BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿

    MDR report key: 12271301 · Received August 3, 2021

    Report

    Report Number
    1119779-2021-01278
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 8, 2021
    Report Date
    March 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    UDI-DI
    10382902222399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DURING MANUFACTURING OF MATERIAL 222239, MEDIA IS FORMULATED AND SENT THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN. THE PETRI DISHES ARE SUBJECTED TO UV RADIATION TO DECREASE BIOBURDEN. THE PETRI DISHES ARE FILLED IN A POSITIVE PRESSURE HEPA FILTERED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED INTO SLEEVES TO DECREASE THE INTRODUCTION OF MICROBES. SLEEVES ARE THEN PACKAGED INTO CARTONS AND THEN TRANSFERRED TO A REFRIGERATED TRUCK (2 TO 8 DEGREES C) FOR SHIPMENT TO THE DISTRIBUTOR. BD DISTRIBUTORS ARE PROVIDED WITH THE STORAGE GUIDELINES FOR THE SHIPPING AND HANDLING OF BD MEDIA OF 2 TO 8 DEGREES C IN A DARK PLACE. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. ONE PHOTO SHOWS THE BOTTOM OF A TAPED BI-PLATE WITH NO PLATE PRINT. ANOTHER PHOTO SHOWS A TAPED STACK OF SIX BI-PLATES AND THERE IS NO PLATE PRINT ON THE TOP PLATE. THE LAST PHOTO SHOWS THE BOTTOM OF SIX BI-PLATES WITHOUT A PLATE PRINT ON EACH PLATE. NO OTHER PRODUCT LABELS ARE VISIBLE IN THE PHOTOS FOR BATCH VERIFICATION. NO RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. NO BATCH NUMBER WAS PROVIDED FOR INVESTIGATION OF THIS COMPLAINT. RETENTION SAMPLES CANNOT BE EVALUATED WITHOUT A SPECIFIC BATCH NUMBER. TRENDING WAS PERFORMED ON THE APPROPRIATE QUALITY DATABASES AND NO TRENDS FOR MISSING PLATE PRINT WERE FOUND IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221270 AND THERE ARE NO COMPLAINT TRENDS FOR MISSING PLATE PRINT OVER THE LAST 12 MONTHS. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 6 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER REPORTS RECEIVING 6 222239 PLATES THAT HAD NO PLATE STAMP ON THEM FOR IDENTIFICATION. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT WHILE USING 6 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER REPORTS RECEIVING 6 222239 PLATES THAT HAD NO PLATE STAMP ON THEM FOR IDENTIFICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163392 BD BBL¿ CHROMAGAR¿ ORIENTATION AND BBL¿ TRYPTICASE¿ SOY AGAR (TSA II)-I PLATE¿ CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 222239 UNKNOWN 10382902222399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown