BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17421820 · Received July 30, 2023

    Report

    Report Number
    1917413-2023-00700
    Event Type
    Malfunction
    Date Received
    July 30, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 25, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION. OF THOSE, 10 SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OVERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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.

    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#: 3016600; D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2023; H4. DEVICE MANUFACTURE DATE: 16-JAN-2023. D4. MEDICAL DEVICE LOT#: 3111759; D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2024; H4. DEVICE MANUFACTURE DATE: 21-APR-2023. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES ARE OVERFILLING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING OVERFILLING OF TUBES. AFFECTED LOT NUMBERS 3016600 AND 3111759. CUSTOMER STATED THEY ARE HAVING OVERFILLING ISSUES WITH THE BD VACUTAINER CITRATE TUBES FROM LOT NUMBER 3111759 AND 3016600. TO RULE OUT PHLEBOTOMY TECHNIQUE AS THE ROOT CAUSE, CUSTOMER HAD A PHLEBOTOMIST DRAW FROM HER USING BOTH LOT NUMBERS AND BOTH WERE OVERFILLED. THERE HAS BEEN NO PATIENT HARM OTHER THAN MULTIPLE DRAWS WERE DONE BECAUSE OF THE OVERFILLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES ARE OVERFILLING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING OVERFILLING OF TUBES. AFFECTED LOT NUMBERS 3016600 AND 3111759. CUSTOMER STATED THEY ARE HAVING OVERFILLING ISSUES WITH THE BD VACUTAINER CITRATE TUBES FROM LOT NUMBER 3111759 AND 3016600. TO RULE OUT PHLEBOTOMY TECHNIQUE AS THE ROOT CAUSE, CUSTOMER HAD A PHLEBOTOMIST DRAW FROM HER USING BOTH LOT NUMBERS AND BOTH WERE OVERFILLED. THERE HAS BEEN NO PATIENT HARM OTHER THAN MULTIPLE DRAWS WERE DONE BECAUSE OF THE OVERFILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605257 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown