BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL LITHIUM HEPARINN BLOOD COLLECTION TUBES

    MDR report key: 7625078 · Received June 21, 2018

    Report

    Report Number
    1917413-2018-03050
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 24, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD RECEIVED SAMPLES AND PHOTOS FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE INDICATED FAILURE MODE FOR FIBRIN CLOTTING WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER AND RETENTION SAMPLES WERE TESTED AND NO ISSUES RELATING TO FIBRIN CLOTTING WERE OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. EACH COMPLAINT LOT WAS TESTED AGAINST 4 SUBJECTS, INCLUDING A CONTROL LOT WITH THE TROPONIN-I ASSAY PERFORMED WITH 4 REPLICATES PER TUBE. ALL REPLICATES SHOWED EXCELLENT REPRODUCIBILITY. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION IN ORDER TO IDENTIFY EMERGING TRENDS. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ERRONEOUS RESULTS. IT WAS STATED THE CONSUMER IS ¿SPINNING AT 3800 RPM (2038RCF) FOR 10 MINUTES INS A SWING BUCKET CENTRIFUGE. THEY HAVE TROPONIN OUTLINERS AND WHEN THEY ALIQUOT OFF THE PLASMA AND RESPIN THEY ARE SEEING FIBRIN AND SOMETIMES A CELL BUTTON. THEY HAVE BEEN HAVING THIS PROBLEM SINCE MARCH WHEN SHE STATES THEY FILED A PIR WITH 4 DIFFERENT LOTS. SAMPLES WERE SENT BACK AT THAT TIME. SPECIMENS WERE NOT REFRIGERATED BUT SPUN IMMEDIATELY AFTER CENTRIFUGATION. SITE STATES THAT THE STAFF IS INFORMED TO MIX SAMPLES 8-10 TIMES UPON DRAWING. INSTRUMENT HAS BEEN CHECKED OUT FOR ANY ISSUES AND THERE ARE NONE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ERRONEOUS RESULTS. IT WAS STATED THE CONSUMER IS ¿SPINNING AT 3800 RPM (2038RCF) FOR 10 MINUTES INS A SWING BUCKET CENTRIFUGE. THEY HAVE TROPONIN OUTLINERS AND WHEN THEY ALIQUOT OFF THE PLASMA AND RESPIN THEY ARE SEEING FIBRIN AND SOMETIMES A CELL BUTTON. THEY HAVE BEEN HAVING THIS PROBLEM SINCE MARCH WHEN SHE STATES THEY FILED A PIR WITH 4 DIFFERENT LOTS. SAMPLES WERE SENT BACK AT THAT TIME. SPECIMENS WERE NOT REFRIGERATED BUT SPUN IMMEDIATELY AFTER CENTRIFUGATION. SITE STATES THAT THE STAFF IS INFORMED TO MIX SAMPLES 8-10 TIMES UPON DRAWING. INSTRUMENT HAS BEEN CHECKED OUT FOR ANY ISSUES AND THERE ARE NONE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8032770, EXPIRATION DATE: 2019-02-28, MANUFACTURE DATE: 2018-02-01. MEDICAL DEVICE LOT #: 8011591, EXPIRATION DATE: 2019-02-28, MANUFACTURE DATE: 2018-02-01. MEDICAL DEVICE LOT #: 8011592, EXPIRATION DATE: 2019-02-28, MANUFACTURE DATE: 2018-02-01. MEDICAL DEVICE LOT #: 7340955, EXPIRATION DATE: 2019-02-28, MANUFACTURE DATE: 2018-02-01. 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 WITH THE USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH ERRONEOUS RESULTS. IT WAS STATED THE CONSUMER IS ¿SPINNING AT 3800 RPM (2038RCF) FOR 10 MINUTES INS A SWING BUCKET CENTRIFUGE. THEY HAVE TROPONIN OUTLINERS AND WHEN THEY ALIQUOT OFF THE PLASMA AND RESPIN THEY ARE SEEING FIBRIN AND SOMETIMES A CELL BUTTON. THEY HAVE BEEN HAVING THIS PROBLEM SINCE (B)(6) WHEN SHE STATES THEY FILED A PIR WITH 4 DIFFERENT LOTS. SAMPLES WERE SENT BACK AT THAT TIME. SPECIMENS WERE NOT REFRIGERATED BUT SPUN IMMEDIATELY AFTER CENTRIFUGATION. SITE STATES THAT THE STAFF IS INFORMED TO MIX SAMPLES 8-10 TIMES UPON DRAWING. INSTRUMENT HAS BEEN CHECKED OUT FOR ANY ISSUES AND THERE ARE NONE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468132 BD VACUTAINER® PST¿ GEL LITHIUM HEPARINN BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. SEE H.10 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Other