BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 10773265 · Received November 2, 2020

    Report

    Report Number
    1917413-2020-01045
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 7, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678780
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD RECEIVED 2 SAMPLES AND 4 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE IS THAT THE EMBEDDED FM IS INDICATIVE OF RESIN COLORANT AND/OR RESIN ADHERING TO THE INTERIOR OF THE MOLD CORE AND BREAKING FREE DURING PRODUCTION. THIS WOULD TYPICALLY BE SEEN DURING THE START OF A RUN, OR IF THE MOLD HAD TO BE STOPPED FOR MAINTENANCE AND THEN RESTARTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367929) FROM LOT 0072531: SPOT IN TUBE X2."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL.. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367929) FROM LOT 0072531: SPOT IN TUBE X2."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234854 BD VACUTAINER LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367878 0072531 50382903678780

    Patients

    Seq Age Sex Outcome Treatment
    1