BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17936198 · Received October 13, 2023

    Report

    Report Number
    9617032-2023-01460
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 20, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD RECEIVED 67 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE VISUALLY INSPECTED AND 36 OUT OF 67 TUBES HAD NO ADDITIVE. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER 2023. FURTHER CLINICAL TESTING IS NOT INDICATED SINCE 36 OF THE 67 RETURNED SAMPLES HAD NO ADDITIVE. 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 FIBRIN AND MISSING ADDITIVE BASED ON THE RETURNED SAMPLE TESTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE MISSING ADDITIVE FAILURE. MISSING ADDITIVE WOULD CONTRIBUTE TO FIBRIN FORMATION. 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. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 23-NOV-2023.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES DEVICE COULD NOT ASPIRATE FROM TUBE USING THE ANALYZER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: WE HAD A PROBLEM WITH 1 CARTON OF BD GEL DRY TUBES LOT N°3073186. THE SEPARATION OF THE FIBRIN WAS NOT DONE CORRECTLY AFTER WAITING FOR 30 MINUTES AND CENTRIFUGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES DEVICE COULD NOT ASPIRATE FROM TUBE USING THE ANALYZER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: WE HAD A PROBLEM WITH 1 CARTON OF BD GEL DRY TUBES LOT N°3073186. THE SEPARATION OF THE FIBRIN WAS NOT DONE CORRECTLY AFTER WAITING FOR 30 MINUTES AND CENTRIFUGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748900 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3073186 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown