BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8895748 · Received August 14, 2019

    Report

    Report Number
    1024879-2019-01427
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 5, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT 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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES LABELS LIFTED OFF. THIS OCCURRED ON 5 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9081745. IT WAS REPORTED THAT THE LABELS ARE PEELING UP. YELLOW AND GREEN VACUTAINERS LABELS ARE PEELING UP. NUMEROUS VIALS WHERE EITHER THE LABELS ARE PEELING UP OR THE MACHINE DID NOT PRESS THEM DOWN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES LABELS LIFTED OFF. THIS OCCURRED ON 5 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9081745. IT WAS REPORTED THAT THE LABELS ARE PEELING UP. YELLOW AND GREEN VACUTAINERS LABELS ARE PEELING UP. NUMEROUS VAILS WHERE EITHER THE LABELS ARE PEELING UP OR THE MACHINE DID NOT PRESS THEM DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685325 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9081745 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other