BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7455856 · Received April 24, 2018

    Report

    Report Number
    1917413-2018-00860
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 10, 2017
    Report Date
    September 4, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR BATCH 6253530 WITH NO ISSUES BEING IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE SAMPLE IS DRAWING SLOWLY. THERE WAS REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO SAMPLES OR PHOTOGRAPHS WERE RECEIVED FROM THE CUSTOMER AT THE TIME OF THIS REPORT. DHR/BHR REVIEW: NO DHR REVIEW WAS DONE. UNCONFIRMED. NO SAMPLE OR PHOTOGRAPH RECEIVED IN SUPPORT OF THIS COMPLAINT AT THE TIME OF THIS REPORT. ROOT CAUSE DESCRIPTION: THE MOST LIKELY ROOT CAUSE FOR THIS TYPE OF DEFECT WILL BE DOCUMENTED IN PIC (B)(4) OR LOW DRAW. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR EVALUATION OF CURRENT TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE SAMPLE IS DRAWING SLOWLY. THERE WAS REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299717 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 6253530 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other