BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER® LH PST¿ BLOOD COLLECTION TUBES

    MDR report key: 19520760 · Received June 12, 2024

    Report

    Report Number
    2243072-2024-00695
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 23, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR PLASMA (BUBBLES) WAS UNABLE TO BE CONFIRMED: PHOTOS PROVIDED ARE PHOTOS THAT ARE TAKEN DIRECTLY ABOVE THE TUBES WHEN THE SAMPLE IS PIPETTED BY THE ANALYZER. POOR PLASMA/BUBBLES CANNOT BE IDENTIFIED FROM THE PHOTOS PROVIDED AS THE TUBE TYPE CANNOT BE CONFIRMED. IN ADDITION, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL AND LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY 2024. ERRONEOUS RESULT TESTING COULD NOT BE PERFORMED WITHOUT A MATERIAL AND LOT # PROVIDED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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

    IT WAS REPORTED WHILE USING AN UNSPECIFIED BD VACUTAINER® LH PST¿ BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBER OF ERRONEOUS TROPONIN RESULTS AND ISSUES WITH ASPIRATING SAMPLES IN AN AUTOMATED INSTRUMENT DUE TO FOAMING/POOR PLASMA WERE OBSERVED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161247 UNSPECIFIED BD VACUTAINER® LH PST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown