BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC: 1.0ML

    MDR report key: 7098137 · Received December 7, 2017

    Report

    Report Number
    1917413-2017-00443
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    February 13, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR EXCESS ADDITIVE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND 203 PIECES OF THE 13,600 CHECKED TUBES FROM LOT 6182782 HAVE A DEFECT: 83 TUBES HAVE DUST IN TUBE; 7 TUBES HAVE TOO MUCH CITRATE; 49 TUBES HAVE DAMAGED ETIQUETTES; 59 TUBES HAVE SCRATCH MARKS ON GLASS; 2 TUBES ARE BROKEN; 2 TUBES WITH NO CITRATE; 1 TUBE WITHOUT GEL. CONCLUSION: LINKED COMPLAINT PR # (B)(4) HAS CONFIRMED THE ISSUES PRESENT IN THIS LOT NUMBER. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REGEN¿ THT® NC: 1.0MLHAD EXCESS ADDITIVE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877945 REGEN¿ THT® NC: 1.0ML BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 6182782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other