BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11109051 · Received January 4, 2021

    Report

    Report Number
    1024879-2020-00980
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    November 29, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679893
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED 7 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FM IN GEL AND DIRTY TUBE WITH THE INCIDENT LOT 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL THIS EVENT OCCURRED 7 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THE FOLLOWING ISSUES WERE FOUND IN TUBES (367989) FROM LOT 0170702: FM IN GEL ×6. DIRTY TUBE X1.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER(R) SST" BLOOD COLLECTION TUBES EXPERIENCED FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL THIS EVENT OCCURRED 7 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: THE FOLLOWING ISSUES WERE FOUND IN TUBES (367989) FROM LOT 0170702: FM IN GEL X6, DIRTY TUBE X1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8264 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367989 0170702 50382903679893

    Patients

    Seq Age Sex Outcome Treatment
    1