BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 8400334 · Received March 7, 2019

    Report

    Report Number
    1917413-2019-00946
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 18, 2019
    Report Date
    April 2, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    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

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BD HAS FOLLOWED UP WITH THE CUSTOMER TO PROVIDE TROUBLESHOOTING. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD HEMOLYSIS. THE FOLLOWING WAS REPORTED, "IT WAS REPORTED THE CUSTOMER EXPERIENCED HEMOLYSIS PROBLEMS INTERMITTENTLY. OVER THE YEARS, I HAVE ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND RARELY, EVEN AFTER EDUCATION, A TECH MAY STILL HAVE A HIGH HEMOLYSIS RATE ON CHEMISTRY TUBES. WE NOTE IT MOST THERE BECAUSE OF ANALYTES HIGHLY SENSITIVE TO HEMOLYSIS SUCH AS K+, MG+, AST, ALT, LDH AND A FEW OTHERS. FROM 2008 TO 2012, THE HEMOLYSIS INDEX GIVEN BY THE MACHINES WAS ACCURATE AND COULD BE VERIFIED BY OTHER METHODOLOGY. NOT SO MUCH NOW. PLEASE TELL ME WHAT THE VACUUM PRESSURE IS FOR EACH OF THE FOLLOWING TUBES:"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR: 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 A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAD HEMOLYSIS. THE FOLLOWING WAS REPORTED, "IT WAS REPORTED THE CUSTOMER EXPERIENCED HEMOLYSIS PROBLEMS INTERMITTENTLY. OVER THE YEARS, I HAVE ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND RARELY, EVEN AFTER EDUCATION, A TECH MAY STILL HAVE A HIGH HEMOLYSIS RATE ON CHEMISTRY TUBES. WE NOTE IT MOST THERE BECAUSE OF ANALYTES HIGHLY SENSITIVE TO HEMOLYSIS SUCH AS K+, MG+, AST, ALT, LDH AND A FEW OTHERS. FROM 2008 TO 2012, THE HEMOLYSIS INDEX GIVEN BY THE MACHINES WAS ACCURATE AND COULD BE VERIFIED BY OTHER METHODOLOGY. NOT SO MUCH NOW. PLEASE TELL ME WHAT THE VACUUM PRESSURE IS FOR EACH OF THE FOLLOWING TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194961 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other