BEUDAMED
    FDA Adverse Event Injury Summary report: N

    13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 6742038 · Received July 25, 2017

    Report

    Report Number
    1917413-2017-00075
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    December 28, 2016
    Report Date
    September 25, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THREE LOT NUMBERS FOR THIS INCIDENT WERE PROVIDED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6253706, EXPIRATION DATE: 1/31/2018, MANUFACTURE DATE: 9/92016. MEDICAL DEVICE LOT #: 6253709, EXPIRATION DATE: 1/31/2018, MANUFACTURE DATE: 9/9/2016. MEDICAL DEVICE LOT #: 6253710, EXPIRATION DATE: 1/31/2018, MANUFACTURE DATE: 9/9/2016. DEVICE EVALUATION: RESULTS: BD DID NOT RECEIVE SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM THE INCIDENT LOTS WERE SELECTED FOR TESTING. ALL TUBES PERFORMED AS EXPECTED AND NO PRODUCT ISSUES WERE OBSERVED DURING THE INVESTIGATION. 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. CONCLUSION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RESULTS OF INTERNAL TESTING SHOW ACCEPTABLE PERFORMANCE. BASED ON FOLLOW UP WITH THE CUSTOMER, PATIENT CONDITIONS WERE A POTENTIAL ROOT CAUSE FOR THE REPORTED ELEVATED READING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSING HOME PATIENT'S HGB TEST RESULTS WERE CRITICALLY LOW AT 6.9. A 13 X 75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE WAS USED FOR THIS TEST. THE PATIENT WAS TRANSFERRED TO A HOSPITAL WHERE REPEAT TESTING WAS DONE AND THE HGB RESULT WAS 8.9. THE TEST RESULTS WERE IDENTIFIED AS AN ISSUE WITH THE PATIENT'S CONDITION BEING THAT HE/SHE WAS EDEMATOUS WITH 40 POUNDS WORTH OF FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520925 13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention