BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.45 ML 13X75 MM BUFFERED SODIUM CITRATE 9NC BD VACUTAINER®

    MDR report key: 7007758 · Received November 7, 2017

    Report

    Report Number
    1917413-2017-00347
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 2, 2015
    Report Date
    November 6, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR ABNORMAL ADDITIVE WITH THE INCIDENT LOT WAS OBSERVED. ONE SAMPLES WAS EVALUATED FOR THE DISCOLORED ADDITIVE. THE TUBE WAS OUT OF SPECIFICATION REQUIREMENTS FOR CITRATE COMPOSITION. SOURCE OF DISCOLORATION COULD NOT BE IDENTIFIED DURING ANALYSIS. REMAINING NINETEEN TUBES ANALYZED FOR DRAW VOLUME. DRAW VOLUME WAS WITHIN SPECIFICATION. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT # 5041595 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: ROOT CAUSE IS UNCLEAR. ABNORMAL ADDITIVE IS LIKELY DUE TO MANUFACTURING DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADDITIVE BD VACUTAINER® GLASS STERILE COAGULATION TUBE, SILICONIZED INTERIOR, 0.129M BUFFERED SODIUM CITRATE, LT. BLUE CONVENTIONAL STOPPER, PAPER LABEL, 4.5ML, 13X75MM HAD A BROWN HUE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785490 4.45 ML 13X75 MM BUFFERED SODIUM CITRATE 9NC BD VACUTAINER® BLOOD COLLECTION TUBES JKA BECTON, DICKINSON & CO. 5041595

    Patients

    Seq Age Sex Outcome Treatment
    1 Other