BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 17344398 · Received July 18, 2023

    Report

    Report Number
    1119779-2023-00783
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902218235
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL 221823 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. 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 CUSTOMER DID NOT PROVIDE A BATCH NUMBER, PHOTOS OR RETURNS FOR THIS COMPLAINT INVESTIGATION. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR TRYPTICASE SOY BROTH (TSB 15ML) (MATERIAL 221823) AND NO QUALITY NOTIFICATION TRENDS HAVE BEEN IDENTIFIED FOR THIS MATERIAL FOR BROKEN/CRACKED TUBES OR CONTAMINATION IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221823 AND THERE ARE NO TRENDS FOR BROKEN OR CRACKED TUBES OR CONTAMINATION IN THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND COMPLAINTS FOR THESE ISSUES. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON MATERIAL TRENDING. NO ADDITIONAL ACTIONS ARE INDICATED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS CONTAMINATION OF AN UNSPECIFIED NUMBER OF PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT THEY HAVE PREVIOUS RECEIVED LOTS THAT HAD CONTAMINATED TUBES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH, THERE WAS CONTAMINATION OF AN UNSPECIFIED NUMBER OF PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT THEY HAVE PREVIOUS RECEIVED LOTS THAT HAD CONTAMINATED TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766548 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) 221823 UNKNOWN 30382902218235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown