BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 12025739 · Received June 18, 2021

    Report

    Report Number
    1119779-2021-01004
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 19, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902210932
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: MATERIAL 221093 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 0245498 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION, FILLING AND LABELING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0245498 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO LABELING DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. THE LABELING PROCESS FOR MATERIAL 221093 INCLUDES LABEL RECONCILIATION WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS APPLIED TO TUBES, AFFIXED TO 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 0245498 SHOWS THERE WAS NOT A SHORTAGE OR EXCESS OF LABELS AFTER THE MANUFACTURING. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A PACKAGING LABEL ON A SHIPPING BOX. THE SECOND PHOTO SHOWS A TUBE FROM BATCH 0245498. ALSO NOTED IS A SHIPPING RECEIPT FOR BATCH 0294209. NO OTHER OBSERVATIONS CAN BE MADE FROM THE PHOTOS. THE PRODUCT IS NOT MISLABELED, EITHER THE WRONG SHIPPING RECEIPT OR PRODUCT WAS RECEIVED WITH THE ORDER. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED BY THE PHOTOS PROVIDED. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING LOT NUMBER ON TUBE LABELS DOESN¿T MATCH LOT NUMBER ON PACKAGING LABELS FOR PRODUCT 221093".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTING LOT NUMBER ON TUBE LABELS DOESN¿T MATCH LOT NUMBER ON PACKAGING LABELS FOR PRODUCT 221093".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924157 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221093 0245498 30382902210932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown