BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17873246 · Received October 4, 2023

    Report

    Report Number
    9617032-2023-01323
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 3, 2023
    Report Date
    October 4, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3086937. D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024. H4. DEVICE MANUFACTURE DATE: 27-MAR-2023. D4. MEDICAL DEVICE LOT#: 3010335. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H4. DEVICE MANUFACTURE DATE: 10-JAN-2023. H.6 INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. ONE PHOTOGRAPH INDICATED LOW DRAW, AND SECOND PHOTO INDICATED COLLAPSED TUBE. ADDITIONALLY, 20 RETAINED SAMPLES LOT 3086937 WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 20 TUBES DREW WITHIN SPECIFICATION. 100 RETAINED SAMPLES LOT 3010335 WERE VISUALLY INSPECTED, AND NO COLLAPSED TUBES WERE FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, 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. NOTE THAT FOR COLLAPSED TUBES 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. TO ENSURE THAT TUBES DRAW TO AN ACCEPTABLE VOLUME A NUMBER OF FACTORS SHOULD BE CONSIDERED: EVACUATED TUBES ARE DESIGNED TO DRAW THE VOLUME INDICATED. FILLING IS COMPLETE WHEN VACUUM NO LONGER CONTINUES TO DRAW. WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE A DISCARD TUBE SHOULD BE DRAWN FIRST TO ENSURE THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ IS FILLED WITH BLOOD. THE QUANTITY OF BLOOD DRAWN VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, AGE OF THE TUBE, VENOUS PRESSURE AND FILLING TECHNIQUE. TUBES WITH SMALLER DRAW VOLUMES (PARTIAL DRAW TUBES DENOTED BY TRANSLUCENT CLOSURES) MAY FILL MORE SLOWLY, DUE TO THE LOWER VACUUM, THAN TUBES OF THE SAME SIZE WITH LARGER DRAW VOLUMES. KEY FACTORS TO ENSURE THE CORRECT VACUUM DRAW: ENSURE STORAGE TEMPERATURE IS CORRECT (4°C - 25°C). ENSURE THE BLOOD COLLECTION SYSTEM IS ASSEMBLED CORRECTLY. ENSURE A DISCARD TUBE IS USED WITH A BLOOD COLLECTION SET. ENSURE PROPER NEEDLE POSITIONING IN THE PATIENT¿S VEIN DURING THE VENIPUNCTURE. ENSURE THE TUBE IS PLACED CENTRALLY IN THE NEEDLE HOLDER FOR COMPLETE PUNCTURE OF THE STOPPER. 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 THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES APPEARED DEFORMED AND THERE WAS NO NEGATIVE PRESSURE DURING BLOOD DRAWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. THE CUSTOMER DISCOVERED THAT THE BLOOD COLLECTION TUBE BODY WAS DEFORMED DURING THE PROCESS OF DRAWING BLOOD FROM THE PATIENT, AND IMMEDIATELY STOPPED BLOOD COLLECTION. 2. WHEN THE CUSTOMER DRAWS BLOOD FROM THE PATIENT, THERE IS NO NEGATIVE PRESSURE IN THE TUBE AND NO BLOOD ENTERS THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466814 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown