BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE.

    MDR report key: 7080709 · Received December 4, 2017

    Report

    Report Number
    1917413-2017-00521
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    September 6, 2016
    Report Date
    November 14, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JCF
    UDI-DI
    00382903627608
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR SERUM/PLASMA WITH THE INCIDENT LOT WAS OBSERVED. HOWEVER, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COUPLE OF THE BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE HAD UNEXPECTED PRESENTATION OF BLOOD DRAWS AFTER CENTRIFUGATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859276 BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE. BLOOD COLLECTION TUBE. JCF BECTON, DICKINSON & CO. UNKNOWN 00382903627608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other