BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 12200141 · Received July 20, 2021

    Report

    Report Number
    1917413-2021-00663
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 6, 2021
    Report Date
    August 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678865
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT A PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL. 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® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM DOING OBSERVATIONS AT A SITE AND I WATCHED PHLEB COLLECT QFT GREEN 6ML LITHIUM HEP TUBE AND IT IS NOT FILLING. LOT # 0072519". COMMENTS: 7/7/2021. CUSTOMER CALLED BACK, AND STATED THAT THE TUBES FROM THIS LOT # FILL ABOUT 1 ML SHORT. SHE HAS NOT HEARD ABOUT ANY ISSUES WITH THE NEW LOT # THEY ARE USING. THEY ARE DRAWN WITH STRAIGHT NEEDLES AND THE SST TUBES DRAWN WITH THE HEPARIN TUBES FILL APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    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® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM DOING OBSERVATIONS AT A SITE AND I WATCHED PHLEB COLLECT QFT GREEN 6ML LITHIUM HEP TUBE AND IT IS NOT FILLING. LOT # 0072519". COMMENTS: 7/7/2021 : CUSTOMER CALLED BACK, AND STATED THAT THE TUBES FROM THIS LOT # FILL ABOUT 1 ML SHORT. SHE HAS NOT HEARD ABOUT ANY ISSUES WITH THE NEW LOT # THEY ARE USING. THEY ARE DRAWN WITH STRAIGHT NEEDLES AND THE SST TUBES DRAWN WITH THE HEPARIN TUBES FILL APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094397 BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367886 0072519 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1