BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ GRAM DECOLORIZER

    MDR report key: 20695402 · Received November 15, 2024

    Report

    Report Number
    1119779-2024-00896
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 17, 2024
    Report Date
    January 15, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTS
    UDI-DI
    30382902125274
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE GRAM DECOLORIZER 250ML, CATALOG NUMBER 212527, BATCH 4172034, COMPLAINT # (B)(4) FOR A MISSING LABEL. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A BATCH HISTORY REVIEW OF THE GRAM DECOLORIZER. THE BATCH HISTORY RECORD REVIEW INDICATED NO DEVIATIONS. THE LABEL RECONCILIATION FORM WAS ALSO REVIEWED, AND IT WAS NOTED THERE WAS A (B)(4) DEVIATION BETWEEN THE NUMBER OF LABELS ISSUED AND THE NUMBER OF LABELS THAT REMAINED. THIS PERCENTAGE IS WITHIN THE ALLOWABLE LIMITS PER THE LABEL ACCOUNTABILITY POLICY ESTABLISHED IN OUR PROCEDURE. ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THIS ISSUE FOR THIS CATALOG NUMBER. NO RETURN WAS RECEIVED, BUT THREE PHOTOS WERE RECEIVED. THE FIRST PHOTO WAS OF A TOP VIEW OF FOUR BOTTLES WITH SHIPPING CAPS IN A PLASTIC TRAY. THERE ARE LABELS APPARENT ON THE LEFT TWO BOTTLES AND THE RIGHT-MOST BOTTLE. THE LABELS ARE APPARENT BD LABELS WITH ONLY THE CATALOG NUMBER CLEARLY VISIBLE ON THE RIGHT-MOST BOTTLE. THE SECOND PHOTO IS A FRONT VIEW OF APPARENTLY THE FOUR BOTTLES DEPICTED IN THE FIRST PHOTO, HOWEVER THEY APPEAR TO BE IN REVERSE ORDER FROM PHOTO NUMBER ONE. THE LABELING IS MORE CLEARLY VISIBLE INDICATING THE BOTTLES ARE GRAM DECOLORIZER. THE LEFT-MOST BOTTLE AND THE TWO RIGHT BOTTLES HAVE VISIBLE LABELS WITH HANDWRITTEN WORDING AND NUMBERING IN RED INK. THE WORDING APPEARS TO BE AN ABBREVIATION OF THE WORD ¿RECEIVED¿ AND THE NUMBERING APPEARS TO BE A DATE. THE BOTTLE SECOND FROM THE LEFT DOES NOT SHOW A LABEL. THE THIRD PHOTO DEPICTS A HAND HOLDING A BOTTLE OF GRAM DECOLORIZER CATALOG NUMBER 212527, BATCH NUMBER 4172034, EXPIRATION DATE 2025-12-31. THE BOTTLE HAS THE SAME HAND-WRITTEN LETTERING AND NUMBERING IN RED INK AS THOSE BOTTLES DEPICTED IN PHOTO NUMBER TWO. THIS COMPLAINT IS CONFIRMED. MANUFACTURING HAS BEEN NOTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING THE BD BBL¿ GRAM DECOLORIZER THE USER NOTED A BOTTLE DID NOT HAVE A LABEL AND COULD NOT BE USED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING THE BD BBL GRAM DECOLORIZER THE USER NOTED A BOTTLE DID NOT HAVE A LABEL AND COULD NOT BE USED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91851 BD BBL¿ GRAM DECOLORIZER STAINS, CHEMICAL SOLUTION JTS BECTON DICKINSON & CO. (SPARKS) 4172034 30382902125274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown