BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS CITRATE TUBE

    MDR report key: 7117090 · Received December 14, 2017

    Report

    Report Number
    9617032-2017-00530
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    December 13, 2016
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. THE CORRECT 510K NUMBER ASSOCIATED WITH THIS DEVICE IS K013971.

    Additional Manufacturer Narrative · 1

    REPORT: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MISSING LABEL WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION AS BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLEBOTOMIST NOTICED THAT THERE WAS NO LABEL ON THE BD VACUTAINER® PLUS CITRATE TUBE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895403 BD VACUTAINER® PLUS CITRATE TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6257577 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other