BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL & LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES

    MDR report key: 7956222 · Received October 11, 2018

    Report

    Report Number
    1917413-2018-03566
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 18, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679619
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8011588. MEDICAL DEVICE EXPIRATION DATE: 2019-01-31. DEVICE MANUFACTURE DATE: 2018-01-11. MEDICAL DEVICE LOT #: 8061750. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31. DEVICE MANUFACTURE DATE: 2018-03-02. 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. BD HAS CONDUCTED FURTHER FOLLOW UP WITH THE CUSTOMER AND DISCUSSED PROPER HANDLING AND CENTRIFUGATION. THE CUSTOMER INDICATED THAT THEY BELIEVED THE ISSUE WAS RELATED TO PREANALYTICAL VARIABLES AND WILL CONTINUE TO MONITOR FOR FURTHER ISSUES. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL & LITHIUM HEPARIN (LH) 65 UNITS BLOOD COLLECTION TUBES EXHIBITED ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797177 BD VACUTAINER® PST¿ GEL & LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. SEE H.10 50382903679619

    Patients

    Seq Age Sex Outcome Treatment
    1 Other