BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12277424 · Received August 4, 2021

    Report

    Report Number
    1917413-2021-00703
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 27, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TEN (10) RETENTION SAMPLES OF EACH LOT 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. H3 OTHER TEXT : SEE H.10

    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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I AM REACHING OUT TO YOU BECAUSE THE LITHIUM HEPARIN TUBES HAS A DEFECT! THE TUBES AREN'T FILLING UP AS THEY SHOULD BE. SHORT DRAWS WHICH IS CAUSING TNP'S FOR OUR EMPLOYEES.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #:0345794 . MEDICAL DEVICE EXPIRATION DATE:2022-05-31. DEVICE MANUFACTURE DATE:2020-12-10. MEDICAL DEVICE LOT #: 0316376. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30 . DEVICE MANUFACTURE DATE: 2020-11-11. MEDICAL DEVICE LOT #: 0072519 MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2020-03-12. 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I AM REACHING OUT TO YOU BECAUSE THE LITHIUM HEPARIN TUBES HAS A DEFECT! THE TUBES AREN'T FILLING UP AS THEY SHOULD BE. SHORT DRAWS WHICH IS CAUSING TNP'S FOR OUR EMPLOYEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170544 BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367886 SEE H.10. 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1