BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 15760009 · Received November 9, 2022

    Report

    Report Number
    1917413-2022-00700
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 21, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678414
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6. INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES AND NO PHOTOS WERE RECEIVED IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367841, LOT NUMBER 2080642. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. 10 PRODUCTION LOT IN-HOUSE RETENTION TUBES WERE INSPECTED WITH 0 VISIBLE DEFECTS. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON THE 10-PRODUCTION LOT IN-HOUSE RETENTION TUBES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS. (REFER TO ATTACHED DRAW SHEET) BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES OF UNDERFILL BASED ON THE INVESTIGATION COMPLETED. NO SAMPLES WERE RECEIVED, AND THE DEFECT WAS NOT OBSERVED IN THE RETENTION SAMPLE TESTING. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USE OF THE TUBE, THE TUBE HAD A NO DRAW ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USE OF THE TUBE, THE TUBE HAD A NO DRAW ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2442856 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367841 2080642 50382903678414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown