BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 12333855 · Received August 17, 2021

    Report

    Report Number
    1024879-2021-00594
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    August 2, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-16. H6: INVESTIGATION SUMMARY: BD RECEIVED TWO (2) SHELF PACKS FOR INVESTIGATION. THIRTY (30) SAMPLES FROM EACH LOT WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR BLOOD POOLING WITH THE INCIDENT LOTS WAS NOT OBSERVED. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO BLOOD POOLING 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF BLOOD POOLING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS BLOOD POOLING IN STOPPER WELL AND SAMPLE LEAKAGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE BLOOD DROPLETS ON THE STOPPER AFTER BLOOD COLLECTION AND THERE IS LEAKAGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1048269, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2021-02-17, MEDICAL DEVICE LOT #: 1020574, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2021-01-20. 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 WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS BLOOD POOLING IN STOPPER WELL AND SAMPLE LEAKAGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE ARE BLOOD DROPLETS ON THE STOPPER AFTER BLOOD COLLECTION AND THERE IS LEAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230818 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1