BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 16188777 · Received January 17, 2023

    Report

    Report Number
    1917413-2023-00038
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 8, 2022
    Report Date
    November 2, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2228620 MEDICAL DEVICE EXPIRATION DATE: 2023-08-31 DEVICE MANUFACTURE DATE: 2022-08-16 MEDICAL DEVICE LOT #: 2132121 MEDICAL DEVICE EXPIRATION DATE: 2023-05-31 DEVICE MANUFACTURE DATE: 2022-05-12 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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CLOSURE SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF CLOSURE SEPARATION WAS NOT OBSERVED. THE 90 RETENTIONS FROM BOTH LOTS WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. 10 RETENTION SAMPLES FROM BOTH LOTS WERE DRAW TESTED WITH ALL WEIGHTS BEING WITHIN SPECIFICATION LIMITS OF 1.62ML ¿ 2.20ML. NO ISSUES WITH THE HEMOGARD CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING DURING OR AFTER THE DRAW TESTING WAS COMPLETED. 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. 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.

    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 PULLED OUT OF THE TUBE WITHIN A HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE IS NOT PROPERLY DECAPPING, LEAVING JUST THE GRAY PIECE, ONLY REMOVING THE LIGHT GREEN."

    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 PULLED OUT OF THE TUBE WITHIN A HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBE IS NOT PROPERLY DECAPPING, LEAVING JUST THE GRAY PIECE, ONLY REMOVING THE LIGHT GREEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109648 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367962 SEE H.10 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown