BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9355322 · Received November 21, 2019

    Report

    Report Number
    1024879-2019-02004
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 31, 2019
    Report Date
    March 30, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679817
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR ERRONEOUS RESULTS WITH THE INCIDENT LOT WAS NOT OBSERVED. 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. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETENTION LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367981 BATCH NO. 9064643, 9123804, 9123802. COMPLAINT 1 OF 3. STARTED SEEING INCREASE IN AUGUST AND HAS BEEN INCREASING IN FREQUENCY. NO VISIBLE HEMOLYSIS. CUSTOMER IS WELL VERSED IN TROUBLESHOOTING AND HAS ADDITIONAL DATA IF NEEDED. PROBLEM K+'S ARE NOT LIMITED TO ONE SITE OR PHLEBOTOMIST, NURSE. TUBES ARE DRAW IN VARIOUS MANNER-STRAIGHT, LINES ETC. THEY MIX 5 TIMES, CLOT AT LEAST 30 MINUTES, NO RESPINNING, SPINNING ACCORDING TO RECOMMENDATIONS, USE CORRECT ORDER OF DRAW. THEIR REFERENCE RANGE IS 3.6-5.2 AND THEY ARE RUNNING UP TO 6.4 CURRENTLY. THEY RUN ON A BECKMAN DXCI 600. THEY DO NOT DRAW OR RUN PLASMA SAMPLES. THERE IS NO VISIBLE HEMOLYSIS. THEY HAVE DECANTED AND SENT THE SERUM TO (B)(4) AND THEY GET THE SAME RESULTS. SHE HAD HER PHLEBOTOMY SUPERVISOR DRAW PATIENTS USING 4 SST TUBES LABELLED 1,2,3,AND 4. THE RESULTS WERE AS FOLLOWS FOR TUBES,1,2,3 AND 4. 5.0, 5.0, 5.5, 5.0 SECOND PATIENT 5.4, 6.1, 5.3, 5.4. SHE ALSO HAD A PATIENT THAT HAD BEEN RUNNING AT 4.4 AND WAS DRAWN IN AM AND WAS 5.3 AND UPON REDRAW AT 12:30 WAS 4.1. CUSTOMER DIDN'T HAVE RATE OF HIGH K+ BUT REPORT THAT THEY ARE HAVING MORE HIGH K+ MORE FREQUENTLY THAN LAST YEAR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9064643. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-03-05. MEDICAL DEVICE LOT #: 9123804. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2019-05-03. MEDICAL DEVICE LOT #: 9123802. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2019-05-03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367981, BATCH NO. 9064643, 9123804, 9123802. COMPLAINT 1 OF 3. STARTED SEEING INCREASE IN AUGUST AND HAS BEEN INCREASING IN FREQUENCY. NO VISIBLE HEMOLYSIS. CUSTOMER IS WELL VERSED IN TROUBLESHOOTING AND HAS ADDITIONAL DATA IF NEEDED. PROBLEM K+'S ARE NOT LIMITED TO ONE SITE OR PHLEBOTOMIST, NURSE. TUBES ARE DRAW IN VARIOUS MANNER-STRAIGHT, LINES ETC. THEY MIX 5 TIMES, CLOT AT LEAST 30 MINUTES, NO RESPINNING, SPINNING ACCORDING TO RECOMMENDATIONS, USE CORRECT ORDER OF DRAW. THEIR REFERENCE RANGE IS 3.6-5.2 AND THEY ARE RUNNING UP TO 6.4 CURRENTLY. THEY RUN ON A BECKMAN DXCI 600. THEY DO NOT DRAW OR RUN PLASMA SAMPLES. THERE IS NO VISIBLE HEMOLYSIS. THEY HAVE DECANTED AND SENT THE SERUM TO LABCORP AND THEY GET THE SAME RESULTS. SHE HAD HER PHLEBOTOMY SUPERVISOR DRAW PATIENTS USING 4 SST TUBES LABELLED 1,2,3,AND 4. THE RESULTS WERE AS FOLLOWS FOR TUBES,1,2,3 AND 4. 5.0, 5.0, 5.5, 5.0 SECOND PATIENT 5.4, 6.1, 5.3, 5.4. SHE ALSO HAD A PATIENT THAT HAD BEEN RUNNING AT 4.4 AND WAS DRAWN IN AM AND WAS 5.3 AND UPON REDRAW AT 12:30 WAS 4.1. CUSTOMER DIDN'T HAVE RATE OF HIGH K+ BUT REPORT THAT THEY ARE HAVING MORE HIGH K+ MORE FREQUENTLY THAN LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154577 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367981 SEE H.10 50382903679817

    Patients

    Seq Age Sex Outcome Treatment
    1 Other