BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM

    MDR report key: 16575530 · Received March 20, 2023

    Report

    Report Number
    1119779-2023-00305
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 10, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902211960
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "MATERIAL 221196 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE MEDIA IS DISPENSED INTO BOTTLES; CAPS ARE APPLIED MANUALLY THEN TORQUED BY MACHINE PER A STANDARD OPERATING PROCEDURE (SOP). THE BOTTLES ARE THEN LABELED AND TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, BOTTLES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH: 2312524 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 WAS SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH: 2312524 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THE CERTIFICATE OF ANALYSIS STATES THE MEDIA APPEARANCE SHOULD BE LIGHT YELLOW WITH NO MORE THAN 1/3 OF FILL SHOWING ROSE PINK AT THE TOP OF THE MEDIUM AND MEDIUM IS CLEAR YELLOW WHEN HEATED. ALL 10/10 RETENTION SAMPLES MAINTAINED THE COLOR/APPEARANCE WITHIN THE SPECIFICATIONS DESCRIBED BY THE CERTIFICATE OF ANALYSIS. FOR FURTHER INVESTIGATION TWO RETENTION TUBES WERE INCUBATED. ONE TUBE WAS PLACED INTO 20-25-DEGREE CELSIUS, AND ONE RETENTION TUBE WAS PLACED INTO 33-37-DEGREES CELSIUS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES. ONE VIDEO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE VIDEO SHOWS TWO TUBES FROM BATCH: 2312524. THE FIRST TUBE HELD UP IN THE VIDEO THERE DOES APPEAR TO BE POSSIBLY GROWTH OR SEDIMENTATION IN THE TUBE. THE SECOND TUBE THE COLOR AND CLARITY OF THE MEDIA APPEARS LIGHT YELLOW WITH NO MORE THAN 1/3 OF FILL SHOWING ROSE PINK AT THE TOP OF THE MEDIUM AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS (WHEN THE MEDIA IS HEATED IT TURNS A CLEAR YELLOW)."

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL. INITIAL REPORTER ADDR 1: (B)(6). 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 WHILE USING THE BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM THAT THERE WAS CONTAMINATION GROWTH ON THE PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEY HAD GROWTH IN A NEGATIVE CONTROL IN 221196.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM THAT THERE WAS CONTAMINATION GROWTH ON THE PLATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEY HAD GROWTH IN A NEGATIVE CONTROL IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766837 BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM SEE H.10 JSG BECTON, DICKINSON & CO. (SPARKS) 221196 2312524 30382902211960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown