BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 21218003 · Received January 23, 2025

    Report

    Report Number
    1917413-2024-01408
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678861
    PMA / PMN Number
    K901449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 95 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO ISSUES WERE IDENTIFIED. THE RETAINED SAMPLES AND DHR FROM AN UNKNOWN LOT COULD NOT BE INSPECTED DUE TO THE UNIDENTIFIED LOT NUMBER. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOTS 4073032 AND UNKNOWN, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY- HEMOLYSIS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES THERE WERE 16 SAMPLES THAT WERE HEMOLYZED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES THERE WERE 16 SAMPLES THAT WERE HEMOLYZED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421260 BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4073032 30382903678861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown