BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ INDIA INK REAGENT DROPPERS

    MDR report key: 22373450 · Received July 1, 2025

    Report

    Report Number
    1119779-2025-00764
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 9, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTS
    UDI-DI
    30382902611944
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS RR DONNELLEY. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 - BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES WERE VISUALLY EXAMINED, AND NO ISSUES WERE OBSERVED RELATING TO PRECIPITATE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF PRECIPITATE. A ROOT CAUSE WAS UNABLE TO BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 3 OF 8: IT WAS REPORTED WHILE USING BD BBL¿ INDIA INK REAGENT DROPPERS THAT ONE DROPPER HAD GRAINY DYE MAKING IT UNUSABLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    REPORT 3 OF 8: IT WAS REPORTED WHILE USING BD BBL¿ INDIA INK REAGENT DROPPERS THAT ONE DROPPER HAD GRAINY DYE MAKING IT UNUSABLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357614 BD BBL¿ INDIA INK REAGENT DROPPERS STAINS, MICROBIOLOGIC JTS BECTON DICKINSON & CO. (SPARKS) B03H029M 30382902611944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown