BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 16911489 · Received May 11, 2023

    Report

    Report Number
    1917413-2023-00413
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 8, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL# [363083] LOT/BATCH# [2291888 AND 2200056] BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION IN SUPPORT OF THIS COMPLAINT FROM CATALOG 363083, LOT NUMBERS 2291888 AND 2200056. THEREFORE, [100] RETENTION SAMPLES FROM BOTH LOTS WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. 10 PRODUCTION LOT IN-HOUSE RETENTION TUBES FROM BOTH LOTS WERE INSPECTED WITH 0 VISIBLE DEFECTS. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON THE 10-PRODUCTION LOT IN-HOUSE RETENTION TUBES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. 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.

    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 #: 2200056 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-07-19. INITIAL REPORTER E-MAIL: (B)(6). 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 THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THAT THE TUBES ARE NOT PULLING THE CORRECT AMOUNT OF BLOOD, CAUSING REDRAWS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CUSTOMER REPORTS THAT TUBES ARE NOT PULLING THE CORRECT AMOUNT OF BLOOD, CAUSING REDRAWS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THAT THE TUBES ARE NOT PULLING THE CORRECT AMOUNT OF BLOOD, CAUSING REDRAWS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER CUSTOMER REPORTS THAT TUBES ARE NOT PULLING THE CORRECT AMOUNT OF BLOOD, CAUSING REDRAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184120 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 2291888 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown