BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PIVO BLOODCOLLECTON

    MDR report key: 18497532 · Received January 11, 2024

    Report

    Report Number
    1710034-2024-00006
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 15, 2023
    Report Date
    August 9, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    00850984007034
    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

    CORRECTION: THE MATERIAL NUMBER WAS INCORRECTLY DOCUMENTED AT INTAKE AND HAS BEEN CORRECTED TO BE "201-0006". INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    D. LOT # 9453399 WAS PROVIDED, BUT IT WAS NOT FOUND IN OUR SYSTEM FOR THE REPORTED MATERIAL 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

    CORRECTION: THE MATERIAL NUMBER WAS INCORRECTLY DOCUMENTED AT INTAKE AND HAS BEEN CORRECTED TO BE "201-0006".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PIVO BLOOD COLLECTION USED ON PATIENT WHO WAS DIAGNOSED WITH AN INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPRESENTATIVES OF (B)(6) HAVE MADE VERBAL COMMENTS WITH CONCERNS OF INCREASED INFECTIONS IN PATIENTS. MATERIAL 3: 201-0006, LOT: 9453399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917032 BD PIVO BLOODCOLLECTON TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9453399 00850984007034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other