BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 3.6MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 12124303 · Received July 6, 2021

    Report

    Report Number
    9617032-2021-00716
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 100 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 100 TUBES HAD A VERY LOW VACUUM FORCE AND A PROPER VOLUME WASN'T RECEIVED. THE PHLEBOTOMISTS COULDN'T GET ENOUGH BLOOD VOLUME , FOR THE RESEARCHES TO WORK WITH. THEY TOOK 100 TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020133 BD VACUTAINER K2E 3.6MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0133092

    Patients

    Seq Age Sex Outcome Treatment
    1