BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 9513087 · Received December 23, 2019

    Report

    Report Number
    9617032-2019-01547
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 4, 2019
    Report Date
    March 11, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903666435
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO CLOTTING AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT IS REPORTED CUSTOMER EXPERIENCED CLOTTING. WAS TUBE FILLED TO THE PROPER DRAW VOLUME? (YES). HOW MANY TIMES WAS THE TUBE INVERTED? (8 TO 10 TIMES). WAS THE TUBE STORED IN THE REFRIGERATOR? (TUBES WERE STORED AT AMBIENT TEMPERATURE PRIOR TO SAMPLE COLLECTION. FINAL ALIQUOTS WERE STORED AT -80°C). WHAT IS THE TIME FROM COLLECTION TO ANALYSIS? (WITHIN 30 MINUTES OF COLLECTION, BLOOD SAMPLES WERE CENTRIFUGED FOR 15 MINUTES AT 1300 X G , TRANSFERRED TO CRYOVIALS, AND STORED AT -80°C FOR ~3 MONTHS.)" 1 OF 2 COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8155920. MEDICAL DEVICE EXPIRATION DATE: 2019-06-30. DEVICE MANUFACTURE DATE: 2018-06-04. MEDICAL DEVICE LOT #: 8204622. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2018-07-23. MEDICAL DEVICE LOT #: 8295716. MEDICAL DEVICE EXPIRATION DATE: 2019-10-31. DEVICE MANUFACTURE DATE: 2018-10-22. MEDICAL DEVICE LOT #: 9007981. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2019-01-07. MEDICAL DEVICE LOT #: 9056599. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-02-25. MEDICAL DEVICE LOT #: 9092649. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2019-04-02. 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 · 1

    IT WAS REPORTED THAT CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT IS REPORTED CUSTOMER EXPERIENCED CLOTTING. WAS TUBE FILLED TO THE PROPER DRAW VOLUME? (YES). HOW MANY TIMES WAS THE TUBE INVERTED? (8 TO 10 TIMES). WAS THE TUBE STORED IN THE REFRIGERATOR? (TUBES WERE STORED AT AMBIENT TEMPERATURE PRIOR TO SAMPLE COLLECTION. FINAL ALIQUOTS WERE STORED AT -80°C). WHAT IS THE TIME FROM COLLECTION TO ANALYSIS? (WITHIN 30 MINUTES OF COLLECTION, BLOOD SAMPLES WERE CENTRIFUGED FOR 15 MINUTES AT 1300 X G , TRANSFERRED TO CRYOVIALS, AND STORED AT -80°C FOR ~3 MONTHS.)". 1 OF 2 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308896 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 366643 SEE. H.10 50382903666435

    Patients

    Seq Age Sex Outcome Treatment
    1 Other