BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PIVO BLOODCOLLECTON

    MDR report key: 18499893 · Received January 11, 2024

    Report

    Report Number
    1710034-2024-00008
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 15, 2023
    Report Date
    February 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    10850984007024
    PMA / PMN Number
    K190604
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GRID UPDATE AS LOT 092322-02 IS VALID FOR PIVO PRODUCT. THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    BATCH # 092322-02 WAS PROVIDED FOR THIS REPORTED MATERIAL NUMBER. IT IS NOT A VALID LOT NUMBER. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PIVO BLOOD COLLECTION HAD PATIENT WHO WAS DIAGNOSED WITH AN INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPRESENTATIVES OF (B)(6) NETWORK HAVE MADE VERBAL COMMENTS WITH CONCERNS OF INCREASED INFECTIONS IN PATIENTS: MATERIAL 2: 202-0005 LOT: 092322-02

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003309 BD PIVO BLOODCOLLECTON TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 092322-02 10850984007024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other