BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9446198 · Received December 10, 2019

    Report

    Report Number
    2243072-2019-02777
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 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

    MATERIAL NO. 368774. BATCH NO. 190508. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THERE IS AN ISSUE WITH ERRONEOUS RESULTS. THEY ARE SEEING MACRO CLOTS IN THE SERUM OF THE RST TUBES. 3 OF 6: THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT THEY ARE SEEING MICRO AND MACRO CLOTS IN THE SERUM OF THE RST TUBES. THEY INVERT 5 TIMES UPON DRAWING AND SHE DOES NOT HAVE A CLOT TIME BUT STATES THAT THEY ARE SENT VIA PNEUMATIC TUBE SO TIME FROM DRAW TO RECEIPT IS MOST LIKELY 15 MINUTES. THEY REMOVE CLOTS FROM SERUM AND THEN RUN. THEY ARE NOT RUNNING HIGH SENSITIVITY TROPONIN. THEY RUN ON DXI. THEY USE THE RST TUBES FOR TSH, PREGNANCY AND TROPONIN AND HAVE NOT HAD ISSUES WITH THE OTHER ANALYTES. TUBES ARE NOT STORED IN LAB BUT SITE WILL TRY TO GET TUBES FROM EACH LOT# TO SEND BACK.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 368774 BATCH NO. 190508. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THERE IS AN ISSUE WITH ERRONEOUS RESULTS. THEY ARE SEEING MACRO CLOTS IN THE SERUM OF THE RST TUBES. 3 OF 6: THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT THEY ARE SEEING MICRO AND MACRO CLOTS IN THE SERUM OF THE RST TUBES. THEY INVERT 5 TIMES UPON DRAWING AND SHE DOES NOT HAVE A CLOT TIME BUT STATES THAT THEY ARE SENT VIA PNEUMATIC TUBE SO TIME FROM DRAW TO RECEIPT IS MOST LIKELY 15 MINUTES. THEY REMOVE CLOTS FROM SERUM AND THEN RUN. THEY ARE NOT RUNNING HIGH SENSITIVITY TROPONIN. THEY RUN ON DXI. THEY USE THE RST TUBES FOR TSH, PREGNANCY AND TROPONIN AND HAVE NOT HAD ISSUES WITH THE OTHER ANALYTES. TUBES ARE NOT STORED IN LAB BUT SITE WILL TRY TO GET TUBES FROM EACH LOT# TO SEND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243378 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