BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL TB CARBOLFUCHSIN KF

    MDR report key: 11653760 · Received April 12, 2021

    Report

    Report Number
    1119779-2021-00657
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 12, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE FOLLOWING IS INTENDED TO SUMMARIZE THE INVESTIGATION FOR CUSTOMER COMPLAINT (B)(4), MATERIAL 212518, LOT 0237774 FOR PRECIPITATE. 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 REVIEW OF THE BATCH HISTORY RECORD FOR TB CARBOLFUCHSIN KF. THE BATCH HISTORY RECORD REVIEW 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 VIEW OF A BOTTLE OF TB CARBOLFUCHSIN KF FERT # 212518, EXP 2021-09-30. THE LOT NUMBER COVERED BY HAND HOLDING THE BOTTLE. THE SECOND PHOTO DEPICTS A BOTTLE OF TB CARBOLFUCHSIN KF LOT # 0237774. 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 · 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. "IMPURITY. ON 21MAR2021/(B)(4). UPDATE FROM RCC PROVIDED: THERE IS NO CONTAMINATION. YES, IT IS PRECIPITATE IN THE STAIN. USER FOUND THE PURPLE PARTICLE AFTER LOOKING AT THE MICROSCOPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550376 BD BBL TB CARBOLFUCHSIN KF CARBOL FUCHSIN ICL BECTON, DICKINSON & CO. (SPARKS) 212518 0237774 00382902125181

    Patients

    Seq Age Sex Outcome Treatment
    1