BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ LIM BROTH

    MDR report key: 14739446 · Received June 17, 2022

    Report

    Report Number
    1119779-2022-00915
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 24, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSD
    UDI-DI
    00382902962663
    PMA / PMN Number
    K833759
    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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL 296266 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 2005284 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUEING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER CAP DEFECT COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR BROKEN TUBES. RETENTION SAMPLES FROM BATCH 2005284 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THERE WAS NO EVIDENCE OF BROKEN TUBES OBSERVED IN 10/10 RETENTION SAMPLES. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: ¿ THE FIRST PHOTO SHOWS A PARTIAL TUBE FROM BATCH 2005284. THE TUBE IS INSIDE OF A PLASTIC BAG THE TUBE DOES APPEAR TO BE CRACKED AND LEAKING INSIDE OF THE BAG. ¿ THE SECOND PHOTO SHOWS A TUBE FROM BATCH 2005284, INSIDE OF A PLASTIC BAG. THE TUBE DOES APPEAR TO BE BROKEN. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED FROM THE EVIDENCE PROVIDED BY THE PHOTOS. NO ACTIONS ARE INDICATED AT THIS TIME AS NO TRENDS WERE OBSERVED. BD WILL CONTINUE TO TREND COMPLAINTS FOR BROKEN TUBES. BD SHIPS PRODUCT IN TEMPERATURE CONTROLLED TRUCKS TO DISTRIBUTION CENTERS. DISTRIBUTION CENTERS ARE PROVIDED WITH SHIPPING AND STORAGE GUIDELINES. MISHANDLING OF THE PRODUCT AND VIBRATIONS DURING SHIPPING CAN CAUSE BROKEN TUBES. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ LIM BROTH TWO TUBES BROKE IN EMPLOYEE'S HANDS WHEN OPENING. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIM BROTH TUBES 296266 - 2 TUBES BROKE IN (EMPLOYEE) HANDS WHEN OPENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ LIM BROTH TWO TUBES BROKE IN EMPLOYEE'S HANDS WHEN OPENING. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIM BROTH TUBES 296266 - 2 TUBES BROKE IN (EMPLOYEE) HANDS WHEN OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224530 BD BBL¿ LIM BROTH CULTURE MEDIA, SELECTIVE BROTH JSD BECTON, DICKINSON & CO. (SPARKS) 2005284 00382902962663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown