BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12104382 · Received July 1, 2021

    Report

    Report Number
    1917413-2021-00566
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 11, 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 · 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 #: 1040966, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 0345794, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2020-12-10". INVESTIGATION SUMMARY: MATERIAL NO. 367886 LOT NO. 1040966 & 0345794. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 HAD A COMPLAINT WITH BLOOD SPECIMEN TUBES THAT ARE NOT FILLING SUFFICIENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995016 BD VACUTAINER LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367886 0345794 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1