BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE

    MDR report key: 14122220 · Received April 15, 2022

    Report

    Report Number
    1119779-2022-00570
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 18, 2022
    Report Date
    June 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 245122 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 TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1133306 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: 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 WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1133306 (100 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 100/100 RETENTION SAMPLES. TEN UNINOCULATED RETENTION TUBES FROM BATCH 1133306 WERE PLACE INTO INCUBATION TO TEST FOR CONTAMINATION. FIVE TUBES WERE PLACED INTO A 20 TO 25 DEGREES C INCUBATOR AND FIVE TUBES WERE PLACED IN A 33 TO 37 DEGREE C INCUBATOR FOR SEVEN DAYS. AT SEVEN DAYS INCUBATION, THERE WERE NO TRACES OF MICROBIAL GROWTH IN THE 10/10 INCUBATED RETENTION TUBES. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE PHOTO SHOWS A PARTIAL TUBE (THE CAP CANNOT BE OBSERVED) FROM BATCH 1133306. THERE DOES APPEAR TO BE POSSIBLE GROWTH IN THE TUBE CREATING A CLOUDY APPEARANCE. RETURNS WERE ALSO RECEIVED TO ASSIST WITH THE INVESTIGATION. ONE TUBE FROM BATCH 1133306 WAS INSIDE OF A PLASTIC BAG RECEIVED IN A SHIPPING BOX. THE MEDIA IN THE TUBE WAS TURBID. THE TUBE WAS SENT TO THE ID LAB FOR MICROBIAL IDENTIFICATION. THE ID LAB IDENTIFIED THE BACTERIUM AS SPECIES FROM ACINETOBACTER. THE COMPLAINT CAN BE CONFIRMED FROM THE PHOTO AND THE RETURN SAMPLE RECEIVED. A TREND HAS NOT BEEN IDENTIFIED, THEREFORE, THERE ARE NO ACTIONS PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE WAS CONTAMINATED WITH FOREIGN PARTICLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED A TUBE WITH TURBIDITY/PARTICLES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE WAS CONTAMINATED WITH FOREIGN PARTICLES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED A TUBE WITH TURBIDITY/PARTICLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166237 BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBE SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 245122 1133306 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown