BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8214180 · Received January 3, 2019

    Report

    Report Number
    1024879-2018-01552
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 14, 2018
    Report Date
    March 1, 2019
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED BD AWARENESS DATE. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DATE OF EVENT: (B)(6) 2018. DATE RECEIVED BY MANUFACTURER: 2018-12-14.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: 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 THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS HAD ISSUES WITH AIR BUBBLES, INSUFFICIENT BLOOD FLOW, HEMOLYSIS, AND LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS HAD ISSUES WITH AIR BUBBLES, INSUFFICIENT BLOOD FLOW, HEMOLYSIS, AND LEAKAGE.

    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 #: 8201857. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2018-07-20. MEDICAL DEVICE LOT #: 8201861. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2018-07-20. 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 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS HAD ISSUES WITH AIR BUBBLES, INSUFFICIENT BLOOD FLOW, HEMOLYSIS, AND LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4853 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10. 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other