BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 10794841 · Received November 5, 2020

    Report

    Report Number
    1917413-2020-01123
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 16, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS DO NOT SHOW THE CUSTOMER¿S FAILURE MODE OF ¿OVERFILL¿ AS THE MENISCUS OF FLUID IS BELOW THE SHIELD. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED OVERFILL. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE TUBES ARE OVERFILLING. "THERE HAVE BEEN IN INCREASE IN CALLBACKS FROM THE LAB ABOUT OVERDRAWN PT/PTT. THIS IS ASSOCIATED WITH THE PRESSURE IN THE TUBE AND IT NOT EASILY AVOIDED.".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0167176, DEVICE MANUFACTURE DATE: 2020-06-15, MEDICAL DEVICE LOT #: 0100191, DEVICE MANUFACTURE DATE: 2020-04-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED OVERFILL.. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE TUBES ARE OVERFILLING. "THERE HAVE BEEN IN INCREASE IN CALLBACKS FROM THE LAB ABOUT OVERDRAWN PT/PTT. THIS IS ASSOCIATED WITH THE PRESSURE IN THE TUBE AND IT NOT EASILY AVOIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255570 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 0167176 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1