BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS CITRATE TUBE

    MDR report key: 7101282 · Received December 8, 2017

    Report

    Report Number
    9617032-2017-00548
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    February 7, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903630950
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR NO ADDITIVE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR NO ADDITIVE WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: THE ROOT CAUSE / POTENTIAL ROOT CAUSE FOR THE MISSING ADDITIVE WAS DETERMINED TO BE MISHANDLING OF A REJECTED TRAY OF TUBES.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITHOUT A 510K NUMBER BUT THIS DEVICE DOES HAVE A 510K ASSOCIATED WITH IT. THE 510K NUMBER IS K013971.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER WITHDRAWING BLOOD AND BEFORE TESTING ON MACHINE MANY BLOOD SAMPLES IN THE BD VACUTAINER® PLUS CITRATE TUBES HAD CLOTTED. AFTER CHECKING THE UNUSED TUBES 300EA TUBES WITHOUT ADDITIVE WERE FOUND, THESE TUBES WERE FOUND IN 4 CASES AND DISPERSED IN MANY SP. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881325 BD VACUTAINER® PLUS CITRATE TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6277528 00382903630950

    Patients

    Seq Age Sex Outcome Treatment
    1 Other