BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TB CARBOLFUCHSIN KF

    MDR report key: 11644614 · Received April 9, 2021

    Report

    Report Number
    1119779-2021-00638
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    ICL
    UDI-DI
    00382902125181
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD FOR TB CARBOLFUCHSIN KF. THE BATCH HISTORY RECORD REVIEWS INDICATED NO DISCREPANCIES. 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 THE DEFECT IN QUESTION. TWO PHOTOS WERE RECEIVED. THE FIRST PHOTO DEPICTS A MICROSCOPIC VIEW OF A STAIN SLIDE. A MIXTURE OF PURPLE AND BLUE GREEN STAIN CAN BE SEEN. THE SECOND PHOTO DEPICTS A BOTTLE OF TB CARBOLFUCHSIN KF FERT # 212518 LOT # 0237774, EXP 2021-09-30. A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH. THE SOLUTION APPEARANCE WAS SATISFACTORY AND COMPARABLE TO THE CONTROL; BOTH WERE A REDDISH-PURPLE SUSPENSION WITH NO VISIBLE PRECIPITATE, IMPURITIES, OR CONTAMINATION. STAINING WAS COMPLETED PER INSTRUCTIONS IN THE PRODUCT INSERT. SLIDES OF POSITIVE (M. TUBERCULOSIS ATCC 25177) AND NEGATIVE (B. SUBTILIS ATCC 6533) CONTROLS WERE EVALUATED AND GAVE SATISFACTORY STAINING RESULTS WITH THE RETENTION AND CONTROL BATCHES. THE RETENTION WAS COMPARABLE TO THE CONTROL. THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF CONTAMINATION PRECIPITATE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF CONTAMINATION PRECIPITATE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IMPURITY: (B)(6) - UPDATE FROM (B)(6) : THERE IS NO CONTAMINATION. YES, IT IS PRECIPITATE IN THE STAIN. YOU CAN ALSO FIND THE PURPLE PARTICLE IN THE MICROSCOPE PHOTO AS (B)(6) ATTACHED. USER FOUND THE PURPLE PARTICLE AFTER LOOKING AT THE MICROSCOPE. PURPLE PARTICLE COVERED THE STAIN RESULTS. IT INCREASES THE ERROR RISK OF CLINICAL REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543626 BD BBL TB CARBOLFUCHSIN KF CARBOL FUCHSIN ICL BECTON, DICKINSON & CO. (SPARKS) 212518 0237774 00382902125181

    Patients

    Seq Age Sex Outcome Treatment
    1