BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ ACRIDINE ORANGE STAIN

    MDR report key: 16434405 · Received February 24, 2023

    Report

    Report Number
    1119779-2023-00175
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 23, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    IDC
    UDI-DI
    00382902125372
    PMA / PMN Number
    UNKNOWN
    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

    H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE ACRIDINE ORANGE STAIN 250ML 4 EA, CATALOG NUMBER 212537, AND COMPLAINT #(B)(6) FOR ISSUES DIFFERENTIATING BACTERIA. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. COMPLAINT INVESTIGATION TYPICALLY INVOLVES A REVIEW OF THE COMPLAINT BATCH HISTORY RECORD. NO COMPLAINT LOT OF MATERIAL 212537 WAS PROVIDED, THEREFORE NO BATCH HISTORY REVIEW COULD BE PERFORMED. RELEASE TESTING FOR THIS PRODUCT INCLUDES SOLUTION APPEARANCE, AND CULTURAL RESPONSE WITH ORGANISMS AS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. ALL QC RESULTS MUST MEET THE COA SPECIFICATIONS PRIOR TO RELEASE. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO COMPLAINTS ON THIS PRODUCT FOR ANY REASON. NO PHOTOS OR RETURNS WERE RECEIVED. THIS COMPLAINT IS NOT CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING BD BBL¿ ACRIDINE ORANGE STAIN HAS PERFORMANCE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDE THE INTIAL REPORTER: RAPID TEST FOR PRESENCE OF MICROORGANISMS (BACTERIA, YEAST, MOLD) LIMITATIONS OF METHOD MULTIPLE STUDIES MENTIONED ACRIDINE ORANGE¿S INABILITY TO DISCRIMINATE BETWEEN A LIVE AND DEAD CELL. SAW POOR CORRELATION BETWEEN THIS METHOD AND INGREDIENTS WHERE THERE WAS A HIGH LEVEL OF NON-VIABLE BACTERIA DUE TO A PROCESS STEP (E.G. BLANCHING OF VEGETABLES).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING BD BBL¿ ACRIDINE ORANGE STAIN HAS PERFORMANCE ISSUES THE FOLLOWING INFORMATION WAS PROVIDE THE INITIAL REPORTER: RAPID TEST FOR PRESENCE OF MICROORGANISMS (BACTERIA, YEAST, MOLD) LIMITATIONS OF METHOD MULTIPLE STUDIES MENTIONED ACRIDINE ORANGE¿S INABILITY TO DISCRIMINATE BETWEEN A LIVE AND DEAD CELL. SAW POOR CORRELATION BETWEEN THIS METHOD AND INGREDIENTS WHERE THERE WAS A HIGH LEVEL OF NON-VIABLE BACTERIA DUE TO A PROCESS STEP (E.G. BLANCHING OF VEGETABLES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932544 BD BBL¿ ACRIDINE ORANGE STAIN ACRIDINE ORANGE IDC BECTON, DICKINSON & CO. (SPARKS) 212537 UNKNOWN 00382902125372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown