BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10680350 · Received October 14, 2020

    Report

    Report Number
    1917413-2020-00941
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 20, 2020
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THE TUBES OVER FILLED. THIS OCCURRED WITH 30 TUBES FROM EACH LOT, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MULTIPLE LOTS OF BD SODIUM CITRATE TUBES (CAT # 363083) WITH TUBES THAT ARE OVERFILLING. I BELIEVE THE CUSTOMER WILL WANT TO DISCUSS THEIR FINDINGS WITH SOMEONE FROM BD QUALITY TEAM. PLEASE FIND ATTACHED TO THIS PIR A FORMAL STUDY THE CUSTOMER DID REGARDING THEIR REPORTED OVERFILLING ISSUE WITH THE BD SODIUM CITRATE TUBES FROM 3 DIFFERENT LOTS. STUDY: TEN SAMPLE SETS PER LOT THAT CONTAIN THREE (3) BD SODIUM CITRATE VACUTAINER TUBES PER SET WERE COLLECTED AND OBSERVED FOR ADEQUATE FILL VOLUMES. IN EACH SET THERE IS A TUBE COLLECTED VIA VACUTAINER, A TUBE COLLECTED VIA SYRINGE TRANSFER AND A TUBE COLLECTED USING THE BUTTERFLY/VACUTAINER COMBO. ALL SAMPLES WERE SUBJECT TO THE SAME PRE-ANALYTIC CONDITIONS AS CURRENT SPECIMENS. SPECIMENS DID NOT PROCEED TO THE ANALYTICAL AND POST ANALYTICAL STAGES AS ONLY INITIAL COLLECTION SAMPLE INTEGRITY IS BEING TRACKED. ALL BUT TWO (2) SAMPLES WERE DEEMED INADEQUATE DUE TO OVER FILLING. THE TWO (2) THAT WERE ACCEPTABLE WERE LIKELY DUE TO THE COLLECTOR NOT ALLOWING THE TUBE TO PULL ITS FULL VACUUM CAPACITY. ADDITIONALLY, ON 2020-09-30 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "WE SPOKE WITH BD, ON MONDAY, 9/28, WHO EXPLAINED TO US REGARDING THE ACCEPTABLE MINIMUM-MAXIMUM FILL VOLUME GUIDELINE FOR THIS PARTICULAR TUBE. IT WAS DISCOVERED THAT OUR COMPLAINT OF OVERFILLING IS NOT AN ISSUE OTHER THAN EDUCATION AS THE FILL VOLUME WE REPORTED AS ¿OVERFILLING¿ FALLS INTO THE RANGE BETWEEN MIN AND MAX. THEREFORE, THE COMPLAINT CAN BE MARKED AS RESOLVED AS END-USER EDUCATION WAS PERFORMED BY BD, AND IT WAS NOT A LOT OR TUBE ISSUE."

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0100191. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0133231. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2020-05-12. MEDICAL DEVICE LOT #: 0133233. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2020-05-12 ". A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THE TUBES OVER FILLED. THIS OCCURRED WITH 30 TUBES FROM EACH LOT, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MULTIPLE LOTS OF BD SODIUM CITRATE TUBES (CAT # 363083) WITH TUBES THAT ARE OVERFILLING. I BELIEVE THE CUSTOMER WILL WANT TO DISCUSS THEIR FINDINGS WITH SOMEONE FROM BD QUALITY TEAM. PLEASE FIND ATTACHED TO THIS PIR A FORMAL STUDY THE CUSTOMER DID REGARDING THEIR REPORTED OVERFILLING ISSUE WITH THE BD SODIUM CITRATE TUBES FROM 3 DIFFERENT LOTS. STUDY: TEN SAMPLE SETS PER LOT THAT CONTAIN 3 BD SODIUM CITRATE VACUTAINER TUBES PER SET WERE COLLECTED AND OBSERVED FOR ADEQUATE FILL VOLUMES. IN EACH SET THERE IS A TUBE COLLECTED VIA VACUTAINER, A TUBE COLLECTED VIA SYRINGE TRANSFER AND A TUBE COLLECTED USING THE BUTTERFLY/VACUTAINER COMBO. ALL SAMPLES WERE SUBJECT TO THE SAME PRE-ANALYTIC CONDITIONS AS CURRENT SPECIMENS. SPECIMENS DID NOT PROCEED TO THE ANALYTICAL AND POST ANALYTICAL STAGES AS ONLY INITIAL COLLECTION SAMPLE INTEGRITY IS BEING TRACKED. ALL BUT 2 SAMPLES WERE DEEMED INADEQUATE DUE TO OVER FILLING. THE 2 THAT WERE ACCEPTABLE WERE LIKELY DUE TO THE COLLECTOR NOT ALLOWING THE TUBE TO PULL ITS FULL VACUUM CAPACITY. ADDITIONALLY, ON 2020-09-30 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "WE SPOKE WITH BD, ON MONDAY, 9/28, WHO EXPLAINED TO US REGARDING THE ACCEPTABLE MINIMUM-MAXIMUM FILL VOLUME GUIDELINE FOR THIS PARTICULAR TUBE. IT WAS DISCOVERED THAT OUR COMPLAINT OF OVERFILLING IS NOT AN ISSUE OTHER THAN EDUCATION AS THE FILL VOLUME WE REPORTED AS ¿OVERFILLING¿ FALLS INTO THE RANGE BETWEEN MIN AND MAX. THEREFORE, THE COMPLAINT CAN BE MARKED AS RESOLVED AS END-USER EDUCATION WAS PERFORMED BY BD, AND IT WAS NOT A LOT OR TUBE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146370 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