BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19730516 · Received July 12, 2024

    Report

    Report Number
    2243072-2024-00793
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 13, 2024
    Report Date
    June 24, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D4. MEDICAL DEVICE CATALOG #: UNKNOWN. D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2243072-2024-00793 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STUDY WAS CONDUCTED INDICATING THAT UNSPECIFIED BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXHIBIT A BIAS WHEN COMPARED TO GREINER CITRATE/NAF TUBES FOR GLUCOSE TESTING AND RECOMMENDS EITHER TRANSITIONING TO A CITRATE/NAF TUBE OR EMPLOY MATHEMATICAL CORRECTIONS IF UTILIZING GEL SEPARATOR TUBES FOR GLUCOSE TESTING IN THEIR ESTABLISHED PREANALYTICAL PROCESS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STUDY WAS CONDUCTED INDICATING THAT UNSPECIFIED BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXHIBIT A BIAS WHEN COMPARED TO GREINER CITRATE/NAF TUBES FOR GLUCOSE TESTING AND RECOMMENDS EITHER TRANSITIONING TO A CITRATE/NAF TUBE OR EMPLOY MATHEMATICAL CORRECTIONS IF UTILIZING GEL SEPARATOR TUBES FOR GLUCOSE TESTING IN THEIR ESTABLISHED PREANALYTICAL PROCESS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385618 UNSPECIFIED BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown