BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11609324 · Received April 2, 2021

    Report

    Report Number
    1917413-2021-00254
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 12, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION (MATERIAL #367886, LOT #0072519). THEREFORE, 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FRANKLIN PRIMARY BROUGHT TO MY ATTENTION THAT THE TUBES HAVE WEAK SUCTION AND THEY CAN¿T FILL THE VIALS ENOUGH." "RECENTLY WE RECEIVED TWO COMPLAINTS REGARDING LITHIUM HEPARIN HAVING POOR SUCTION. IT WAS BROUGHT TO MY ATTENTION THAT THE TUBES HAVE WEAK SUCTION AND THEY CAN¿T FILL THE VIALS ENOUGH.¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD VACUTAINER¿ LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "(B)(6) BROUGHT TO MY ATTENTION THAT THE TUBES HAVE WEAK SUCTION AND THEY CANT FILL THE VIALS ENOUGH." "RECENTLY WE RECEIVED TWO COMPLAINTS REGARDING LITHIUM HEPARIN HAVING POOR SUCTION. IT WAS BROUGHT TO MY ATTENTION THAT THE TUBES HAVE WEAK SUCTION AND THEY CANT FILL THE VIALS ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508612 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