BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13X75MM,1.8ML BD VACUTAINER®PLUS PLASTIC CITRATE TUBE, BD HEMOGARD¿ CLOSURE

    MDR report key: 6932793 · Received October 9, 2017

    Report

    Report Number
    1917413-2017-00126
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    July 13, 2017
    Report Date
    September 25, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7097584, MEDICAL DEVICE EXPIRATION DATE: 2017-10-31, DEVICE MANUFACTURE DATE: 2017-04-07, MEDICAL DEVICE LOT #: 7033864, MEDICAL DEVICE EXPIRATION DATE: 2017-08-31, DEVICE MANUFACTURE DATE: 2017-02-02. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FROM EACH OF THE INCIDENT LOTS FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE OF LOW DRAW VOLUME WITH ONE OF THE INCIDENT LOTS WAS OBSERVED. WATER FILL TESTING WAS CONDUCTED ON THE CUSTOMER SAMPLES AND ONE SAMPLE WAS BELOW THE REQUIRED SPECIFICATIONS. THE SAMPLES WERE RECEIVED THE DAY PRIOR TO EXPIRATION OF THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT NUMBERS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BASED ON EVALUATION OF THE CUSTOMER SAMPLES THAT WERE RECEIVED, THE CUSTOMER¿S INDICATED FAILURE MODE OF LOW DRAW VOLUME WITH THE INCIDENT LOT WAS OBSERVED. UPON TESTING OF THE CUSTOMER SAMPLES, ONE SAMPLE DID NOT MEET THE REQUIRED SPECIFICATIONS. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE MULTIPLE REJECTIONS FROM LABS WHEN USING THE BD VACUTAINER® PLUS PLASTIC CITRATE TUBE 13X75MM, 1.8ML DUE TO UNDER FILLS. THE RESULTED IN REDRAWS BUT THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708333 13X75MM,1.8ML BD VACUTAINER®PLUS PLASTIC CITRATE TUBE, BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other