BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN

    MDR report key: 11887216 · Received May 26, 2021

    Report

    Report Number
    1119779-2021-00904
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 6, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION:MATERIAL 221742 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 BATCHES 1020579 AND 0364886 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THERE ARE NO OTHER COMPLAINTS FOR THESE BATCHES. 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 WAS 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. BATCH 1020579. RETENTION SAMPLES FROM BATCH 1020579 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTIONS TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION FROM BATCH 1020579. ONE RETENTION TUBE WAS INCUBATED IN THE 20-25 DEGREE C INCUBATOR AND THE OTHER TUBE WAS PLACED IN THE 33-37 DEGREE C INCUBATOR. AT THE SEVENTH DAY OF INCUBATION THERE WAS NO SIGNS OF GROWTH OR TURBIDITY. BATCH 0364886. RETENTION SAMPLES FROM BATCH 0364886 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTIONS TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR. FOR INVESTIGATION, TWO RETENTION TUBES WENT INTO INCUBATION FROM BATCH 0364886. ONE RETENTION TUBE WAS INCUBATED IN THE 20-25 DEGREE C INCUBATOR AND THE OTHER TUBE WAS PLACED IN THE 33-37 DEGREE C INCUBATOR. AT THE SEVENTH DAY OF INCUBATION THERE WAS NO SIGNS OF GROWTH OR TURBIDITY. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS THREE PARTIAL TUBES. TWO TUBES ARE FROM BATCH 0364886, AND ONE TUBE FROM BATCH 1020579. THE MEDIA IN THIS PHOTO APPEARS HAZY. THE SECOND PHOTO SHOWS THE MEDIA OF THREE PARTIAL TUBES WHERE THE CAPS CANNOT BE SEEN IN THE PHOTO. THE MEDIA IN THE THREE TUBES APPEARS TO BE TURBID. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED BASED ON THE PHOTOS PROVIDED. THERE ARE NO TREND 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 PRIOR TO USE WITH BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THE MEDIA APPEARS CLOUDY. GRAM STAIN SHOWED MANY NON-VIABLE ORGANISMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER STATED MEDIA IS CLOUDY, PRIOR TO INOCULATION. GRAM STAIN SHOWS MANY NON-VIABLE ORGANISMS. GRAM STAIN SHOWED GRAM NEGATIVE BACILL.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0364886. MEDICAL DEVICE EXPIRATION DATE: 2021-12-29. DEVICE MANUFACTURE DATE: 2020-12-29. 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 · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN THE MEDIA APPEARS CLOUDY. GRAM STAIN SHOWED MANY NON-VIABLE ORGANISMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER STATED MEDIA IS CLOUDY, PRIOR TO INOCULATION. GRAM STAIN SHOWS MANY NON-VIABLE ORGANISMS. GRAM STAIN SHOWED GRAM NEGATIVE BACILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780355 BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221742 1020579 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown