BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 10630639 · Received October 5, 2020

    Report

    Report Number
    9617032-2020-00779
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 12, 2020
    Report Date
    February 24, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, 30 RETENTION SAMPLES FROM EACH INCIDENT LOT WERE SELECTED FROM BD INVENTORY AND WERE ANALYZED FOR EDTA CONTENT; ALL WERE FOUND TO BE WITHIN SPECIFICATION. THE CUSTOMER HAS INDICATED THAT THE REPORTED CONDITION WAS NOTED IN SIGNIFICANTLY UNDERFILLED EDTA TUBES ("SUB OPTIMALLY FILLED"). THIS IS CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AND WE RECOMMEND THAT THIS PRODUCT BE FILLED TO THE STATED FILL VOLUME TO ASSURE THE PROPER BLOOD TO ANTICOAGULANT RATIO. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES THE PLATELET COUNTS ARE INCONSISTENT. THERE WAS NO REPORT OF PATIENT IMPACT. (3 OF 3 COMPLAINTS). A SMALL NUMBER OF EDTA SAMPLE TUBES HAVE BEEN GIVING IMPEDANCE PLATELET COUNTS THAT ARE INCONSISTENT WITH PREVIOUS COUNTS. TYPICALLY A PATIENT KNOWN TO RUN A PLATELET COUNT OF 150-200 WILL GIVE 400-600. IF THE ANALYSIS IS REPEATED ADDING IN AN OPTICAL PLATELET COUNT THE OPTICAL PLATELET COUNT WILL BE CONSISTENT WITH HISTORICAL RESULTS WHEREBY THE REPEAT IMPEDANCE COUNT WILL REMAIN INCORRECTLY HIGH. THIS PATTERN IS REPRODUCIBLE ACROSS DIFFERENT ANALYZERS. MOST OF THE SAMPLES WE HAVE SEEN GIVING THIS ERROR HAVE BEEN SUB OPTIMALLY FILLED. DATE: LAB NUMBER: LOT NUMBER: EXP: FILL: IMPEDANCE PLTS: OPTICAL PLTS: (B)(6) 2020, (B)(6), 0112585, AUG-21, SUB OPTIMAL, 449, 282. (B)(6) 2020, (B)(6), 0112585, AUG-21, SUB OPTIMAL, 606, 306. (B)(6) 2020, (B)(6), 0094578, JUL-21, SUB OPTIMAL, 463, 267. (B)(6) 2020, (B)(6), 0112585, AUG-21, SUB OPTIMAL, 1012, 547. (B)(6) 2020, (B)(6), 0112585, AUG-21, SUB OPTIMAL, 677, 342. (B)(6) 2020, (B)(6), 0094578, JUL-21, SUB OPTIMAL, 946, 501. (B)(6) 2020, (B)(6), 0094578, JUL-21, SUB OPTIMAL, 494, 193. (B)(6) 2020, (B)(6), 0094578, JUL-21, SUB OPTIMAL, 705, 438. AT THE MOMENT WE DO NOT KNOW THE ROOT OF THE PROBLEM BUT ALL OF THESE SAMPLES ARRIVED IN THE LAB AT THE SAME TIME & SEEM TO COME FROM 2 BATCH NUMBERS OF BD EDTA TUBES.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0094578, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2020-04-03, MEDICAL DEVICE LOT #: 0112585, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2020-04-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® K2E 7.2MG PLUS BLOOD COLLECTION TUBES THE PLATELET COUNTS ARE INCONSISTENT. THERE WAS NO REPORT OF PATIENT IMPACT. (3 OF 3 COMPLAINTS) A SMALL NUMBER OF EDTA SAMPLE TUBES HAVE BEEN GIVING IMPEDANCE PLATELET COUNTS THAT ARE INCONSISTENT WITH PREVIOUS COUNTS. TYPICALLY A PATIENT KNOWN TO RUN A PLATELET COUNT OF 150-200 WILL GIVE 400-600. IF THE ANALYSIS IS REPEATED ADDING IN AN OPTICAL PLATELET COUNT THE OPTICAL PLATELET COUNT WILL BE CONSISTENT WITH HISTORICAL RESULTS WHEREBY THE REPEAT IMPEDANCE COUNT WILL REMAIN INCORRECTLY HIGH. THIS PATTERN IS REPRODUCIBLE ACROSS DIFFERENT ANALYZERS. MOST OF THE SAMPLES WE HAVE SEEN GIVING THIS ERROR HAVE BEEN SUB OPTIMALLY FILLED. DATE LAB NUMBER LOT NUMBER EXP FILL IMPEDANCE PLTS OPTICAL PLTS 12.09.2020 B,20.6177403.P 0112585 AUG-21 SUB OPTIMAL 449 282 12.09.2020 B,20.6177736.Z 0112585 AUG-21 SUB OPTIMAL 606 306 12.09.2020 B,20.6177744.A 0094578 JUL-21 SUB OPTIMAL 463 267 12.09.2020 B,20.6177969.R 0112585 AUG-21 SUB OPTIMAL 1012 547 12.09.2020 B,20.6178532.E 0112585 AUG-21 SUB OPTIMAL 677 342 12.09.2020 B,20.6177391.L 0094578 JUL-21 SUB OPTIMAL 946 501 12.09.2020 B,20.6177408.R 0094578 JUL-21 SUB OPTIMAL 494 193 12.09.2020 B,20.6178184.Q 0094578 JUL-21 SUB OPTIMAL 705 438 AT THE MOMENT WE DO NOT KNOW THE ROOT OF THE PROBLEM BUT ALL OF THESE SAMPLES ARRIVED IN THE LAB AT THE SAME TIME & SEEM TO COME FROM 2 BATCH NUMBERS OF BD EDTA TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089415 BD VACUTAINER K2E 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other