BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TB CARBOLFUCHSIN KF

    MDR report key: 13545001 · Received February 16, 2022

    Report

    Report Number
    1119779-2022-00248
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 24, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    ICL
    UDI-DI
    00382902125181
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: 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. THREE PHOTOS WERE ATTACHED TO THE COMPLAINT SUBMISSION. THE FIRST TWO PHOTOS DEPICT A MICROSCOPIC VIEW WITH PURPLE STAIN. THE THIRD PHOTO DEPICTS ONE BOTTLE OF MATERIAL 212518, TB CARBOLFUCHSIN KF, LOT NUMBER 1194748, EXPIRATION DATE 2022/07/31. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH OF TB CARBOLFUCHSIN KF. 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. BD WAS UNABLE TO REPLICATE THE PRECIPITATE DEFECT DESCRIBED BY THE CUSTOMER. THIS COMPLAINT CANNOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ TB CARBOLFUCHSIN KF PRECIPITATE AND IMPURITIES WERE FOUND IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMPURITES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BBL¿ TB CARBOLFUCHSIN KF PRECIPITATE AND IMPURITIES WERE FOUND IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMPURITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939738 BD BBL¿ TB CARBOLFUCHSIN KF CARBOL FUCHSIN ICL BECTON, DICKINSON & CO. (SPARKS) 212518 1194748 00382902125181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown