BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 10569834 · Received September 22, 2020

    Report

    Report Number
    1917413-2020-00859
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903697149
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBE HAS A BROWN STAIN IN THE TUBE. THE UPPER TUBE HAS A BROWN STAIN (LOWER IS NORMAL TUBE) AND SITE SUSPECT IT MAY BE CONTAMINATED. COULD YOU SEND THE PICTURE FOR VENDOR AND LET THEM EXPLAIN WHETHER IF THIS TUBE CAN BE USE? AND WHY? THE CATALOG NO. IS 369714, LOT NO. IS 9344028."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBE HAS A BROWN STAIN IN THE TUBE. THE UPPER TUBE HAS A BROWN STAIN (LOWER IS NORMAL TUBE) AND SITE SUSPECT IT MAY BE CONTAMINATED. COULD YOU SEND THE PICTURE FOR VENDOR AND LET THEM EXPLAIN WHETHER IF THIS TUBE CAN BE USE? AND WHY? THE CATALOG NO. IS 369714, LOT NO. IS 9344028."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035592 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 369714 9344028 50382903697149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other