BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE

    MDR report key: 19169976 · Received April 24, 2024

    Report

    Report Number
    1917413-2024-00350
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 4, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679219
    PMA / PMN Number
    K901449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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, CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS. E.1. INITIAL REPORTER ADDR 1: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K945952, K901449.

    Description of Event or Problem · 0

    REPORT 8 OF 8. IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE THE SAMPLES WERE CLOTTING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462652 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3136079 30382903679219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown