BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 23770374 · Received December 10, 2025

    Report

    Report Number
    1917413-2025-01643
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    October 30, 2025
    Report Date
    April 28, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FMH
    UDI-DI
    30382903649922
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). E1. INITIAL REPORTER FACILITY NAME: (B)(6). 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 RECEIVED 3 PHOTOS FOR INVESTIGATION WHICH DID NOT SHOW INDICATED FAILURE MODE OF ER (PROTEIN AND MICROALBUMIN IN ADDITION, 100 RETAINED SAMPLES FROM BOTH LOTS WERE VISUALLY INSPECTED, WITH NO ISSUES BEING IDENTIFIED. FURTHER CLINICAL TESTING COULD NOT BE CONDUCTED AS BD CLINICAL LABORATORIES ARE CURRENTLY UNABLE TO TEST FOR PROTEIN AND MICROALBUMIN IN URINE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5101329, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS-PROTEIN AND MICROALBUMIN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    2 OF 2: IT WAS REPORTED AFTER USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, ERRONEOUS RESULTS, A FALSE POSITIVE IN THE PROTEIN AND MICROALBUMIN WERE SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    2 OF 2: IT WAS REPORTED AFTER USING BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE, ERRONEOUS RESULTS, A FALSE POSITIVE IN THE PROTEIN AND MICROALBUMIN WERE SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269896 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE CONTAINER, SPECIMEN, STERILE FMH BECTON DICKINSON & CO (FRANKLIN LAKES) 5101329 30382903649922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown