BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 13620651 · Received February 28, 2022

    Report

    Report Number
    9617032-2022-00147
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 16, 2022
    Report Date
    February 28, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679572
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO AND 2 VIDEOS WERE PROVIDED FOR INVESTIGATION. THE PHOTO AND VIDEOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL SMEARING WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF GEL SMEARING WAS NOT OBSERVED. 4 RETAINED SAMPLES (BATCH: 1151161) WERE DRAWN WITH HORSE BLOOD, MIXED, AND STOOD AT ROOM TEMPERATURE FOR 30 MINUTES. THEY WERE THEN CENTRIFUGED AT 1300G FOR 10 MINUTES USING AN MSE MISTRAL 1000 CENTRIFUGE. NO GEL SMEARING WAS OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE GEL SMEARING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS GEL SMEARING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING THE COLLECTION OF BLOOD, FOREIGN BODIES THAT LOOKS LIKE STRIPS WERE FOUND IN THE TUBE WALL."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS GEL SMEARING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING THE COLLECTION OF BLOOD, FOREIGN BODIES THAT LOOKS LIKE STRIPS WERE FOUND IN THE TUBE WALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714343 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367957 1151161 50382903679572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown