BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL; TRYPTICASE; SOY BROTH

    MDR report key: 11351614 · Received February 19, 2021

    Report

    Report Number
    1119779-2021-00332
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 28, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217160
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL 221716 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 0281029 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. THE LABELING PROCESS FOR MATERIAL 221716 INCLUDES LABEL RECONCILIATION WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS APPLIED TO TUBES, USED IN THE BATCH HISTORY RECORD, REJECTED AND UNUSED. ANY DISCREPANCIES MUST BE WITHIN ALLOWABLE LIMITS SPECIFIED IN THE LABELING CONTROL PROCEDURE. THE LABEL RECONCILIATION FOR BATCH 0281029 DOES NOT SHOW AN EXCESS OF LABELS AFTER MANUFACTURING WHICH WOULD SUPPORT THE INCIDENCE OF A TUBE WITHOUT A LABEL. QC INSPECTION AND TESTING WAS SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR MISSING LABELS. RETENTION SAMPLES FROM BATCH 0281029 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO CAP, OR TUBE LABEL DEFECT WAS OBSERVED IN 10/10 RETENTION SAMPLES. ALL 10/10 RETENTIONS TUBES HAD A PROPERLY AFFIXED LABEL. NO PHOTOS OR RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING. THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 4 BD BBL¿; TRYPTICASE¿; SOY BROTH THE LABELS WERE NOT ATTACHED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH 4 BD BBL¿; TRYPTICASE¿; SOY BROTH THE LABELS WERE NOT ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249390 BD BBL; TRYPTICASE; SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221716 0281029 30382902217160

    Patients

    Seq Age Sex Outcome Treatment
    1