BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 8921659 · Received August 22, 2019

    Report

    Report Number
    1024879-2019-01500
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678155
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 A 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 57 BD VACUTAINER® SERUM 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: LABEL LIFTING. THE ISSUE WAS OBSERVED DURING THE QA INSPECTION OF THE DISTRIBUTOR DURING SECONDARY REPACKAGING ACTIVITY (REDRESSING) DONE BY THE DISTRIBUTOR.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 #: 9081763. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9081759. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-03-22.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 57 BD VACUTAINER® SERUM 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: LABEL LIFTING. THE ISSUE WAS OBSERVED DURING THE QA INSPECTION OF THE DISTRIBUTOR DURING SECONDARY REPACKAGING ACTIVITY (REDRESSING) DONE BY THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715266 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903678155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other