BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8872028 · Received August 7, 2019

    Report

    Report Number
    1024879-2019-01374
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 LABEL LIFT WITH THE INCIDENT LOT WAS OBSERVED. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA #1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED LABEL LIFT OFF/PARTIAL PEEL OFF WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9081740, 9093706, 9095580. LABELS LIFTING OFF TUBES. THE FOLLOWING LOTS HAVE TUBES WITH THIS ISSUE: ON THE 367986 TUBES: 9081740, 9093706, 9095580. IN THE PAST MONTH, THIS ISSUE HAS BECOME A PROBLEM. THE ONLY BD TUBES THAT HAVE THIS ISSUE ARE THE GOLD TOP TUBES, WE HAVE NOT NOTICED THIS ISSUE ON ANY OTHER TUBE WE CARRY. OUR CURRENT BALANCE RIGHT NOW IS AROUND 20,000. WITHOUT GOING THROUGH 200 PACKS, I THINK IT IS A GOOD ESTIMATION THAT ABOUT 25-50% OF THOSE TUBES ARE GOING TO HAVE SOME FORM OF LABEL LIFT. RIGHT NOW, WE HAVE JUST BEEN PUSHING THE LABELS BACK DOWN TO GET THROUGH THEM.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9081740, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9093706, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-04-03. MEDICAL DEVICE LOT #: 9095580, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-04-05.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED LABEL LIFT OFF/PARTIAL PEEL OFF WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9081740, 9093706, 9095580. LABELS LIFTING OFF TUBES THE FOLLOWING LOTS HAVE TUBES WITH THIS ISSUE: ON THE 367986 TUBES 9081740, 9093706, 9095580. IN THE PAST MONTH, THIS ISSUE HAS BECOME A PROBLEM. THE ONLY BD TUBES THAT HAVE THIS ISSUE ARE THE GOLD TOP TUBES, WE HAVE NOT NOTICED THIS ISSUE ON ANY OTHER TUBE WE CARRY. OUR CURRENT BALANCE RIGHT NOW IS AROUND 20,000. WITHOUT GOING THROUGH 200 PACKS, I THINK IT IS A GOOD ESTIMATION THAT ABOUT 25-50% OF THOSE TUBES ARE GOING TO HAVE SOME FORM OF LABEL LIFT. RIGHT NOW, WE HAVE JUST BEEN PUSHING THE LABELS BACK DOWN TO GET THROUGH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662245 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other