BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA.

    MDR report key: 13097136 · Received December 28, 2021

    Report

    Report Number
    1119779-2021-02054
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 2, 2021
    Report Date
    May 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZI
    UDI-DI
    30382902209097
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 1161580 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FILLING, TORQUEING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS DURING PACKAGING WERE PERFORMED ACCORDING TO PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. ALSO, EACH BATCH HISTORY RECORD WAS REVIEWED TO CONFIRM THE FOLLOWING PRIOR TO RELEASE: --THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. --ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. --THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY FOR THIS BATCH WAS REVIEWED AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1161580 (10 TUBES) WERE AVAILABLE FOR INSPECTION. A CARTON OF 10 TUBES SHOWED NO EVIDENCE OF COLOR OR CONTAMINATION DEFECT FROM VISUAL INSPECTION. ACCORDING TO THE CERTIFICATE OF ANALYSIS SLANT APPEARANCE SHOULD BE LIGHT GREEN TO LIGHT BLUE GREEN ALL 10/10 RETENTION TUBES WERE IN COLOR SPECIFICATIONS WITH THE CERTIFICATE OF ANALYSIS. FOR FURTHER INVESTIGATION OF CONTAMINATION TWO TUBES WENT INTO TESTING. ONE TUBE WAS PLACED IN THE 33 TO 37 DEGREE C INCUBATOR AND ONE TUBE WAS PLACED IN THE 20 TO 25 DEGREE C INCUBATOR. NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES AT SEVEN DAYS INCUBATION. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. TUBES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBIAL GROWTH IN CULTURE MEDIUM TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. TUBES WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBIAL GROWTH IN CULTURE MEDIUM TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995299 BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA. CULTURE MEDIA, ENRICHED KZI BECTON, DICKINSON & CO. (SPARKS) 220909 1161580 30382902209097

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown