BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8453526 · Received March 26, 2019

    Report

    Report Number
    1024879-2019-00643
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. BASED ON THE SEVERITY AND OCCURRENCE OF THE REPORTED CONDITION THERE WILL BE NO FURTHER ACTIONS. REVIEW OF THE EVENT DESCRIPTION CONFIRMED PIC PAS-010-PIC (HEMOLYSIS) WAS APPROPRIATE. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE SEVERITY AND OCCURRENCE OF THE REPORTED CONDITION THERE WILL BE NO FURTHER ACTIONS. REVIEW OF THE EVENT DESCRIPTION CONFIRMED PIC PAS-010-PIC (HEMOLYSIS) WAS APPROPRIATE. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES WERE HEMOLYZED. THIS OCCURRED ON 1000 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "HELLO (B)(6), TODAY WE HAD PROBLEMS WITH THE 5 ML BD SST TUBES, THE SERA THAT WERE LOADED IN THOSE TUBES WERE HEMOLYZED, WE CORROBORATED EVERYTHING THAT COULD BE BUT VERIFYING WITH THE BLOOD COUNTS OF THE SAME PATIENTS THESE ARE NOT HEMOLYZED AND HOWEVER THE SERUMS IF THEN WE ATTRIBUTE THE HEMOLYSIS TO THE TUBES BECAUSE THEY HAVE NO OTHER MANIPULATION BESIDES THEY ARE TAKEN OUT WITH VACUTAINER, I WANTED TO KNOW IF YOU HAD ANY CLAIM REGARDING THIS I SEND YOU THE BATCH OF THE TUBES 8201552 2019 (B)(6)".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES WERE HEMOLYZED. THIS OCCURRED ON 1000 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "HELLO (B)(6), TODAY WE HAD PROBLEMS WITH THE 5 ML BD SST TUBES, THE SERA THAT WERE LOADED IN THOSE TUBES WERE HEMOLYZED, WE CORROBORATED EVERYTHING THAT COULD BE BUT VERIFYING WITH THE BLOOD COUNTS OF THE SAME PATIENTS THESE ARE NOT HEMOLYZED AND HOWEVER THE SERUMS IF THEN WE ATTRIBUTE THE HEMOLYSIS TO THE TUBES BECAUSE THEY HAVE NO OTHER MANIPULATION BESIDES THEY ARE TAKEN OUT WITH VACUTAINER, I WANTED TO KNOW IF YOU HAD ANY CLAIM REGARDING THIS I SEND YOU THE BATCH OF THE TUBES: 8201552, 2019-07-31."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243584 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8201552 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other