BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8870550 · Received August 7, 2019

    Report

    Report Number
    1024879-2019-01361
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    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 THE LABELS WERE PEELING OFF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BEFORE USE. LOT #'S 9091545 AND 9133629 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LABELS LIFTING OFF TUBES. THE FOLLOWING LOTS HAVE TUBES WITH THIS ISSUE: ON THE 367986 TUBES: 9081740, 9093706, 9095580. ON THE 367983 TUBES: 9091545, 9133629. AS FAR AS TIMELINE, IT WAS BROUGHT TO MY ATTENTION A FEW MONTHS AGO, WHEN 1 PK/100 OF THE 367983 TUBES HAD SOME LABEL LIFT. 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 FOR BOTH ARTICLES LISTED ABOVE 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

    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 #: 9091545, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-04-01. MEDICAL DEVICE LOT #: 9133629, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2019-05-13. 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 THE LABELS WERE PEELING OFF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BEFORE USE. LOT #'S 9091545 AND 9133629 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LABELS LIFTING OFF TUBES THE FOLLOWING LOTS HAVE TUBES WITH THIS ISSUE: ON THE 367986 TUBES; 9081740, 9093706, 9095580. ON THE 367983 TUBES; 9091545, 9133629. AS FAR AS TIMELINE, IT WAS BROUGHT TO MY ATTENTION A FEW MONTHS AGO, WHEN 1 PK/100 OF THE 367983 TUBES HAD SOME LABEL LIFT. 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 FOR BOTH ARTICLES LISTED ABOVE 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
    662166 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10. 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other