BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TB STAIN KIT ZN

    MDR report key: 12921040 · Received December 2, 2021

    Report

    Report Number
    1119779-2021-01909
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 29, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTS
    UDI-DI
    00382902125204
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE FOLLOWING SUMMARY IS IN REFERENCE TO THE COMPLAINT, AGAINST MATERIAL 212520, LOT 1207336 FOR SOLUTION APPEARANCE-PARTICULATES. 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 STAIN KIT ZN, LOT 1207336. THE BATCH HISTORY RECORD REVIEWS INDICATED NO DISCREPANCIES. RELEASE TESTING CONSISTS OF COMPONENT APPEARANCE AND PERFORMANCE TESTING USING APPROPRIATE TB STAIN TECHNIQUE. ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO COMPLAINTS AGAINST THIS DYES AND STAINS KIT FOR ANY DEFECTS. NO RETURNS OR PHOTOS WERE RECEIVED. A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH. 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 IS UNABLE TO REPLICATE THE PARTICULATE DEFECT OBSERVED BY THE CUSTOMER IN THE COMPLAINT LOT. CONSEQUENTLY, THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND DYES AND STAINS COMPLAINTS FOR SOLUTION APPEARANCE DEFECTS. IF YOU HAVE FURTHER QUESTIONS, PLEASE CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD BBL¿ TB STAIN KIT ZN WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER OBSERVED PARTICULATES LOOKING LIKE SOLID CIRCLES AFTER STAINING MYCOBACTERIA, AND THE OCCURRENCE WAS OBSERVED WITH BOTH OLD, EXPIRED LOT OF REAGENTS AND WHEN USING A NEW ONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD BBL¿ TB STAIN KIT ZN WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER OBSERVED PARTICULATES LOOKING LIKE SOLID CIRCLES AFTER STAINING MYCOBACTERIA, AND THE OCCURRENCE WAS OBSERVED WITH BOTH OLD, EXPIRED LOT OF REAGENTS AND WHEN USING A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818432 BD BBL¿ TB STAIN KIT ZN STAINS, MICROBIOLOGIC JTS BECTON, DICKINSON & CO. (SPARKS) 212520 UNKNOWN 00382902125204

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown