BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 9447044 · Received December 10, 2019

    Report

    Report Number
    2243072-2019-02783
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CLOTTING IS OCCURRING WITH A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (5 OF 6 COMPLAINTS) IT WAS REPORTED THAT THEY ARE SEEING MICRO AND MACRO CLOTS IN THE SERUM OF THE RST TUBES.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(6) WAS USED AS A PLACE HOLDER BASED ON THE USER FACILITY¿S LOCATION AND AREA CODE. 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 THAT CLOTTING IS OCCURRING WITH A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (5 OF 6 COMPLAINTS) IT WAS REPORTED THAT THEY ARE SEEING MICRO AND MACRO CLOTS IN THE SERUM OF THE RST TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243471 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 368774 190508 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other