BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PSEUDOSEL¿ AGAR

    MDR report key: 14291865 · Received May 5, 2022

    Report

    Report Number
    1119779-2022-00654
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 4, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12-MAY-2022. H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO CATALOG NUMBER 297882, PLATE PSEUDOSEL AGAR CETRIMIDE 10 EA, BATCH NUMBERS 1323562 AND 2061219 FOR PERFORMANCE. DURING MANUFACTURING OF MATERIAL 297882, MEDIA IS FORMULATED USING THE DEHYDRATED CULTURE MEDIA (DCM) WITH USP PURIFIED WATER. MEDIA IS THEN PROCESSED THROUGH A HIGH TEMPERATURE SHORT TIME STERILIZER TO REMOVE BIOBURDEN AND IS ASEPTICALLY DISPENSED DIRECTLY INTO PETRI DISHES. PERSONNEL WORKING IN THE FILLING AREA ARE REQUIRED TO WEAR FULL BODY JUMPSUITS, HOODS, BOOTS, MASKS AND GLOVES. DISPENSING AND SLEEVING ARE COMPLETED WITHIN ISO CERTIFIED ENVIRONMENT. THE FILLED PLATES ARE COOLED AND IMMEDIATELY WRAPPED 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. THE BATCH HISTORY RECORDS FOR BATCHES 1323562 AND 2061219 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. ALL BATCHES ARE TESTED PRIOR TO RELEASE AND RESULTS REPORTED ON THE CERTIFICATE OF ANALYSIS (COA) WHICH CAN BE OBTAINED AT WWW.BD.COM/REGDOCS. ROUTINE STABILITY STUDIES ARE PERFORMED ANNUALLY PER INTERNAL PROCEDURES FOR BIOLOGICAL PERFORMANCE TO ENSURE SATISFACTORY PERFORMANCE THROUGHOUT SHELF LIFE WITH THE ORGANISMS THAT ARE REPORTED ON THE CERTIFICATE OF ANALYSIS OF EACH PRODUCT. STABILITY DATA FOR THIS PRODUCT IS ON FILE. BD RELEASE TESTING FOR THIS PRODUCT IS DESCRIBED IN THE COA AND PACKAGE INSERT AVAILABLE ON BD.COM. TESTING FOR PSEUDOMONAS AERUGINOSA ATCC 9027 FOLLOWS THE GROWTH-PROMOTING TESTING PROTOCOL WHERE 10 TO 100 CFU OF ATCC 9027 FROM FRESH CULTURE IS SPREAD INOCULATED ONTO A TEST PLATE AND CONTROL PLATE. THE PLATES ARE INCUBATED AT 30 TO 35 DEGREES C AND READ AT 18 HOURS. TRACE TO HEAVY GROWTH OF ATCC 9027 AS COMPARED TO THE CONTROL IS EXPECTED ON THE TEST PLATES. ALL PERFORMANCE TESTING ON THESE BATCHES WAS SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED. ONE OTHER COMPLAINT HAS BEEN TAKEN ON BATCH 1323562 FOR PERFORMANCE (AND IS ALSO NOT CONFIRMED) AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 2061219. RETENTION SAMPLES FROM BATCHES 1323562 AND 2061219 WERE NOT AVAILABLE FOR INSPECTION. TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. ONE PHOTO FEATURES A SLEEVE LABEL FROM BATCH 2061219. THE OTHER PHOTO SHOWS THE BOTTOM OF A PLATE FROM BATCH 2061219 (TIME STAMP 0100). THE PLATE DOES NOT APPEAR TO BE USED. TWENTY PLATES FROM BATCH 2061219 ALSO WERE RETURNED AS TWO UNOPENED SLEEVES SHIPPED IN A BOX (TIME STAMP 0058-0100). FOR INVESTIGATION OF THIS COMPLAINT, RETURNED PLATES WERE TESTED WITH ATCC 9027 PER THE STANDARD PERFORMANCE PROTOCOL AS DESCRIBED ABOVE. RETURNED PLATES TESTED HAD GROWTH OF ATCC 9027 AT 18 HOURS INCUBATION ON RETURNED AND CONTROL PLATES. NO RETURN SAMPLES OR PHOTOS FROM BATCH 1323562 WERE RECEIVED FOR INVESTIGATION. ATCC 9027 TESTED SATISFACTORILY IN THE RETURNED PLATES FROM BATCH 2061219. THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE DEFECT IN EITHER BATCH. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ PSEUDOSEL¿ AGAR THERE WAS INSUFFICIENT GROWTH. 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: CUSTOMER REPORTS "25 PAK OF EACH LOT# AFFECTED" IT WAS REPORTED THAT CUSTOMER REPORTS SEVERAL LOT# OF MEDIA 297882 FAILING THE GROWTH PROMOTION FOR ATCC 9027 - PSEUDOMONAS AERUGINOSA. LOT# 1323562, EXP 11MAR2022 (RECEIVED 08FEB2022) FAILED. LOT# 2061219, EXP 16JUN2022 (RECEIVED 04APR2022) FAILED. CALL ACTIVITY COMMENT: ISSUE PRODUCT - FAILED GROWTH PROMOTION CUSTOMER REPORTS SEVERAL LOT# OF MEDIA 297882 FAILING THE GROWTH PROMOTION FOR ATCC 9027 - PSEUDOMONAS AERUGINOSA.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ PSEUDOSEL¿ AGAR THERE WAS INSUFFICIENT GROWTH. 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: CUSTOMER REPORTS "25 PAK OF EACH LOT# AFFECTED." IT WAS REPORTED THAT CUSTOMER REPORTS SEVERAL LOT# OF MEDIA 297882 FAILING THE GROWTH PROMOTION FOR ATCC 9027 - PSEUDOMONAS AERUGINOSA. LOT# 1323562 EXP 11MAR2022 (RECEIVED 08FEB2022) FAILED. LOT# 2061219 EXP 16JUN2022 (RECEIVED 04APR2022) FAILED. CALL ACTIVITY COMMENT: ISSUE PRODUCT - FAILED GROWTH PROMOTION. CUSTOMER REPORTS SEVERAL LOT# OF MEDIA 297882 FAILING THE GROWTH PROMOTION FOR ATCC 9027 - PSEUDOMONAS AERUGINOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694425 BD BBL¿ PSEUDOSEL¿ AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 2061219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown