BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E 3.6MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 12741636 · Received November 2, 2021

    Report

    Report Number
    9617032-2021-01117
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #: BATCH 8082236 DOES NOT EXIST FOR MATERIAL 368841. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS NOT OBSERVED. IN ADDITION, 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. LOT NUMBER [8082236] WAS NOT FOUND FOR MATERIAL NUMBER [368841]. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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: VACUUM DRAWS LESS BLOOD THAN EXPECTED. DRAW VOLUME OF 2ML, TAKES ONLY 0.5-1ML OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635271 BD VACUTAINER K2E 3.6MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1