BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA 3.6MG

    MDR report key: 9175227 · Received October 10, 2019

    Report

    Report Number
    3006948883-2019-00852
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 25, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR HEMOLYSIS WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, THE ISSUE RELATING TO UNDERFILL 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. HEMOLYSIS CAN BE CAUSED BY MANY SOURCES, INCLUDING CERTAIN PATIENT PATHOLOGICAL CONDITIONS, IMPROPER SPECIMEN COLLECTION, SPECIMEN PROCESSING, AND SPECIMEN TRANSPORT. SPECIMEN COLLECTION FACTORS THAT CAN CONTRIBUTE TO HEMOLYSIS RANGE FROM PROLONGED TOURNIQUET TIME AND IMPROPER VENIPUNCTURE TECHNIQUE TO TRANSFERRING A SAMPLE FROM A SYRINGE DRAW OR IV CATHETER. SPECIMEN PROCESSING FACTORS INCLUDE VIGOROUS MIXING OR SHAKING OF THE SPECIMEN, NOT ALLOWING THE SPECIMEN TO CLOT FOR THE RECOMMENDED AMOUNT OF TIME, PROLONGED CONTACT OF SERUM OR PLASMA WITH CELLS, AND EXPOSURE TO EXCESSIVE HEAT OR COLD. FINALLY, MECHANICAL TRAUMA AND OTHER ADVERSE CONDITIONS DURING TRANSPORT OF TUBES CAN RESULT IN HEMOLYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINERS® K2 EDTA 3.6MG EXPERIENCED HEMOLYSIS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S FEEDBACK, THE EDTA TUBE MADE IN SUZHOU OF BD WAS PLACED IN THE REFRIGERATOR FOR ONE DAY AFTER THE COMPLETION OF THE PROJECT, AND THE HEMOLYSIS OCCURRED. HOWEVER, THE SAMPLE CENTRIFUGED IMMEDIATELY AFTER THE BLOOD COLLECTION AND LEFT FOR ONE DAY DID NOT APPEAR HEMOLYSIS. THE SAMPLES SHOWED HEMOLYSIS AFTER STANDING IN THE REFRIGERATOR FOR ONE DAY, AS SHOWN IN FIGURE 1, FIGURE 2 AND FIGURE 3. SUCH SAMPLE WERE NOT CENTRIFUGED, AND THE SAMPLES IN THE EDTA TUBE IMMEDIATELY AFTER BLOOD COLLECTION DID NOT SHOW HEMOLYSIS AFTER STANDING IN THE REFRIGERATOR FOR ONE DAY.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF BD VACUTAINERS® K2 EDTA 3.6MG EXPERIENCED HEMOLYSIS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S FEEDBACK, THE EDTA TUBE MADE IN SUZHOU OF BD WAS PLACED IN THE REFRIGERATOR FOR ONE DAY AFTER THE COMPLETION OF THE PROJECT, AND THE HEMOLYSIS OCCURRED. HOWEVER, THE SAMPLE CENTRIFUGED IMMEDIATELY AFTER THE BLOOD COLLECTION AND LEFT FOR ONE DAY DID NOT APPEAR HEMOLYSIS. THE SAMPLES SHOWED HEMOLYSIS AFTER STANDING IN THE REFRIGERATOR FOR ONE DAY, AS SHOWN IN FIGURE 1, FIGURE 2 AND FIGURE 3. SUCH SAMPLE WERE NOT CENTRIFUGED, AND THE SAMPLES IN THE EDTA TUBE IMMEDIATELY AFTER BLOOD COLLECTION DID NOT SHOW HEMOLYSIS AFTER STANDING IN THE REFRIGERATOR FOR ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968351 BD VACUTAINER® K2 EDTA 3.6MG BLOOD SPECIMEN COLLECTION DEVICE JKA BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9113920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other