BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8006888 · Received October 25, 2018

    Report

    Report Number
    1024879-2018-01313
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8201502, EXPIRATION DATE: 2020-07-31, MANUFACTURE DATE: 2018-07-20. MEDICAL DEVICE LOT #: 8127956, EXPIRATION DATE: 2020-04-30, MANUFACTURE DATE: 2018-05-07. 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 WITH THE USE OF THE BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843795 BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other