BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 15396574 · Received September 9, 2022

    Report

    Report Number
    9617032-2022-00842
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2080645. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2022-03-21. MEDICAL DEVICE LOT #: 2020073. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2022-01-20. INVESTIGATION SUMMARY: MATERIAL NO. 367953. BATCH NO. 2080645, 2020073. BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS WERE PROVIDED BY YOUR FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE INDICATED FAILURE MODES FOR COLLAPSED TUBES AND UNDERFILL WITH THE INCIDENT LOTS WAS OBSERVED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR VISUAL EXAMINATION AND UPON COMPLETION, COLLAPSED TUBES WERE NOT OBSERVED. ADDITIONALLY, TWENTY (20) RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE OF UNDERFILL WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION IN ORDER TO IDENTIFY EMERGING TRENDS. NOTE THAT THERE ARE POTENTIALLY VARYING DEGREES OF TUBE COLLAPSE, BASED ON THE TEMPERATURE AND DURATION OF TIME AT ELEVATED TEMPERATURE. MILDLY COLLAPSED TUBES WILL RETAIN VACUUM AND ONLY SHOW MINIMAL DEFORMATION. MILDLY COLLAPSED TUBES WILL DRAW APPROPRIATELY BUT MAY NOT BE ABLE TO BE PROCESSED ON LABORATORY INSTRUMENTS (E.G. MAY BE SLIGHTLY BOWED AND NO LONGER FIT IN A RACK). AS LONG AS THE VACUUM IS RETAINED AND THE TUBE FILLS APPROPRIATELY, THE TUBE WILL FUNCTION PROPERLY. FULLY COLLAPSED TUBES APPEAR FLATTENED, TWISTED, AND VISIBLY DEFORMED. FULLY COLLAPSED TUBES RETAIN LITTLE OR NO VACUUM AND THEREFORE CANNOT BE DRAWN TO AN APPRECIABLE VOLUME. THESE TUBES ARE EASILY IDENTIFIED BEFORE USE BY THE HEALTHCARE WORKER, SO THERE IS NO POTENTIAL IMPACT TO THE PATIENT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES OF UNDERFILL AND COLLAPSED TUBES FROM RETURNED PHOTOS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR UNDERFILL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE, AS WELL AS COLLAPSED TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BATCH 2080645: DEFORMATION AND INSUFFICIENT VACUUM. BATCH 2020073: INSUFFICIENT VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806747 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367953 2020073 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown