BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ GRAM SAFRANIN

    MDR report key: 24168079 · Received January 23, 2026

    Report

    Report Number
    1119779-2026-00024
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 3, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTS
    UDI-DI
    30382902125311
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE GRAM SAFRANIN 250ML, CATALOG NUMBER 212531, BATCH NUMBER 4242097, COMPLAINT # (B)(4), FOR UNSATISFACTORY PERFORMANCE. 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 BATCH HISTORY REVIEW OF GRAM CRYSTAL VIOLET. 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 FOR THIS PRODUCT. ONE PHOTO WAS RECEIVED. THE PHOTO DEPICTS A MICROSCOPIC VIEW OF GRAM-NEGATIVE CULTURE AND TWO DARK PURPLE NONBACTERIAL ARTIFACTS. RETURN WAS RECEIVED ON 02/26/26 AFTER TESTING WAS COMPLETED. PACKAGE WAS RECEIVED DAMAGED AND SPILLED WITH MIXED MATERIALS. CONTENT INSIDE NOW MIXED MATERIALS AND CAN BE CONTAMINATED. NO FURTHER TESTING CAN BE CONDUCTED THIS TIME A RETENTION SAMPLE FROM THE COMPLAINT BATCH OF GRAM SAFRANIN WAS EVALUATED ALONG WITH A CONTROL BATCH. STAINING WAS COMPLETED PER INSTRUCTIONS IN THE PRODUCT INSERT. SLIDES OF E. COLI ATCC 25922 AND S. AUREUS ATCC 25923 CONTROLS WERE EVALUATED AND HAD SATISFACTORY STAINING RESULTS FOR THE RETENTION AND CONTROL BATCHES. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. THIS COMPLAINT CANNOT BE CONFIRMED. WATERS WILL CONTINUE TO TREND DCM COMPLAINTS FOR UNSATISFACTORY PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM SAFRANIN, THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM SAFRANIN, THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233585 BD BBL¿ GRAM SAFRANIN STAINS, MICROBIOLOGIC JTS BECTON DICKINSON & CO. (SPARKS) 4242097 30382902125311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown