BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9712297 · Received February 14, 2020

    Report

    Report Number
    1917413-2020-00121
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 24, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. THE LEVEL OF BLOOD IN TUBE IS BELOW THE MAXIMUM SUGGESTED FILL LINE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OVERFILL OCCURRED DURING USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "GOOD MORNING! HAVE YOU HEARD FROM ANYONE ABOUT THE BLUE TOPS OVERFILLING? ONE OF OUR CLS BROUGHT A BLUE TOP TO ME TO RECALL THE PATIENT AND IT WAS FILLED ALL THE WAY TO THE TOP. WHEN I WENT TO TALK TO CHECK ON THE LAB ASSISTANT SIDE, THERE WERE OTHER BLUE TOPS THAT ARE OVERFILLED AS WELL. ANY THOUGHTS¿" BOTH INPATIENTS AND OUTPATIENTS. THESE ARE SOME OF THE LOT NUMBERS THAT TUBES WERE OVERFILLED. 9280674, 9260289 AND 9260290. I¿LL SEE IF I CAN PICTURES OF THE TUBES¿THANKS FOR LOOKING INTO THIS.. MUCH APPRECIATED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9280674. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2019-10-07. MEDICAL DEVICE LOT #: 9260289. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-09-17. MEDICAL DEVICE LOT #: 9260290. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-09-17. (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 · 1

    IT WAS REPORTED THAT OVERFILL OCCURRED DURING USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "GOOD MORNING! HAVE YOU HEARD FROM ANYONE ABOUT THE BLUE TOPS OVERFILLING? ONE OF OUR CLS BROUGHT A BLUE TOP TO ME TO RECALL THE PATIENT AND IT WAS FILLED ALL THE WAY TO THE TOP. WHEN I WENT TO TALK TO CHECK ON THE LAB ASSISTANT SIDE, THERE WERE OTHER BLUE TOPS THAT ARE OVERFILLED AS WELL. ANY THOUGHTS¿" BOTH INPATIENTS AND OUTPATIENTS. THESE ARE SOME OF THE LOT NUMBERS THAT TUBES WERE OVERFILLED. 9280674, 9260289 AND 9260290. I¿LL SEE IF I CAN PICTURES OF THE TUBES¿THANKS FOR LOOKING INTO THIS.. MUCH APPRECIATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178238 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE. H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other