BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBE

    MDR report key: 12294846 · Received August 9, 2021

    Report

    Report Number
    1024879-2021-00566
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 19, 2021
    Report Date
    August 31, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-11. H6: INVESTIGATION SUMMARY: BD RECEIVED FOUR (4) SAMPLES FOR INVESTIGATION. ONE (1) SAMPLE FROM EACH LOT WAS EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED IN LOTS 1116456, 1061539, 1123846. THE ONE (1) SAMPLE FROM LOT 1062283 DREW WITHIN SPECIFICATION RANGE AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS NOT OBSERVED. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY FOR EACH OF THE FOUR (4) LOTS WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL DUE TO THE TESTING RESULTS OF THE RETURNED SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER TUBE SEEM TO BE LOSING PRESSURE. IT IS NOT FILLING UP THE TUBE COMPLETELY OR NOT AT ALL. NO SUCTION."

    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 #: 1116456. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-04-26. MEDICAL DEVICE LOT #: 1062283. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2021-03-03. MEDICAL DEVICE LOT #: 1061539. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2021-03-02. MEDICAL DEVICE LOT #: 1123846. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-05-03. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER TUBE SEEM TO BE LOSING PRESSURE. IT IS NOT FILLING UP THE TUBE COMPLETELY OR NOT AT ALL. NO SUCTION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192871 BD VACUTAINER SERUM BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 SEE H.10 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1