BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA.

    MDR report key: 11653783 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00654
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 16, 2021
    Report Date
    September 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    30382902209097
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL 220909 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE THEN PACKED INTO TRAYS AND LOADED ONTO A SLANT RACK CART. THE LOADED CART IS THEN RUN ON A SET INSPISSATION CYCLE PER SOP. POST INSPISSATION, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 0092841 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY HAS BEEN REVIEWED AND THERE ARE NO OTHER COMPLAINTS ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0092841 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THERE WAS NO EVIDENCE OF CONTAMINATION OBSERVED IN 10/10 RETENTION SAMPLES. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION. ONE TUBE WAS INCUBATED AT 20 TO 25 DEGREES CELSIUS, AND ONE TUBE WAS INCUBATED AT 33 TO 37 DEGREES CELSIUS. NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 RETENTION TUBES AT SEVEN DAYS INCUBATION. NO PHOTOS WERE RECEIVED FOR THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. THIS COMPLAINT CANNOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 20 BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. 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: " HAS THE PRODUCT BEEN USED FOR PATIENT TESTING AND WERE THERE ANY ADVERSE EFFECTS IF USED? NO CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION IN PRODUCT 220909 LOT 0092841 - TUBE LOWENSTEIN-JENSEN MED SL A. * STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING:  INITIATED COMPLAINT; REPORTEDLY CONTAMINATED UPON ARRIVAL ".

    Additional Manufacturer Narrative · 1

    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 20 BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. 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: HAS THE PRODUCT BEEN USED FOR PATIENT TESTING AND WERE THERE ANY ADVERSE EFFECTS IF USED? NO. CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION IN PRODUCT 220909 LOT 0092841, TUBE LOWENSTEIN, JENSEN MED SL A. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING:  INITIATED COMPLAINT; REPORTEDLY CONTAMINATED UPON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550523 BD BBL LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 220909 0092841 30382902209097

    Patients

    Seq Age Sex Outcome Treatment
    1