BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE

    MDR report key: 15140886 · Received August 1, 2022

    Report

    Report Number
    1917413-2022-00441
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 17, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 2022-08-04. H.6. INVESTIGATION SUMMARY: BD RECEIVED 100 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT . THE SAMPLES WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED AND THE ISSUE OF STOPPER FUNCTION (STOPPER POP OFF) WAS NOT OBSERVED. ADDITIONALLY, FUNCTIONALLY TESTING WAS PERFORMED ON THE 10-PRODUCTION LOT IN-HOUSE RETENTION TUBES FROM THE BD INVENTORY AND NO ISSUES WERE OBSERVED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE CUSTOMER SAMPLES AND THE RETENTION SAMPLES DID NOT EXHIBIT THE CUSTOMER¿S FAILURE MODE OF ¿STOPPER POP OFF¿. BD IS UNABLE TO DETERMINE A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE TOPS ARE COMING OFF BY THEMSELVES OR WHEN PULLING OUT OF THE CENTRIFUGE FOR CAT 367960 LOT 2080684."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE TOPS ARE COMING OFF BY THEMSELVES OR WHEN PULLING OUT OF THE CENTRIFUGE FOR CAT 367960 LOT 2080684."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942022 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 2080684 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown