BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 10708757 · Received October 20, 2020

    Report

    Report Number
    9617032-2020-00829
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    July 22, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD WAS EXPERIENCED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED ¿BLOOD WAS COLLECTED USING BD SYRINGE, AND THEN TRANSFERRED TO EDTA 2ML 368841 TUBE VIA BTD LOT 9113601 AT INTENSIVE CARE. IT WAS SEEN THAT TUBE WAS NOT FILLED PROPERLY¿

    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 WITH THE USE OF THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD WAS EXPERIENCED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED ¿BLOOD WAS COLLECTED USING BD SYRINGE, AND THEN TRANSFERRED TO EDTA 2ML 368841 TUBE VIA BTD LOT 9113601 AT INTENSIVE CARE. IT WAS SEEN THAT TUBE WAS NOT FILLED PROPERLY¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171954 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 9259567 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1