BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    MDR report key: 24767201 · Received April 2, 2026

    Report

    Report Number
    2647876-2026-00020
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K173873 A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD BACTEC PEDS PLUS F CULTURE VIALS PLASTIC BLOOD CULTURE BOTTLE DURING ARTERIAL BLOOD CULTURE COLLECTION FROM THE LEFT BRACHIAL ARTERY THAT BLOOD REFLUXED THROUGH THE CANNULA WITH AIR ENTRY OBSERVED AT THE TIME OF BOTTLE CONNECTION. THE CANNULA WAS IMMEDIATELY REMOVED, MANUAL PRESSURE WAS APPLIED TO THE INSERTION SITE, THE PATIENT WAS POSITIONED HEAD DOWN WITH FEET ELEVATED, AND THE ON CALL PHYSICIAN WAS NOTIFIED. THE PATIENT DEVELOPED LOCALIZED CYANOSIS INVOLVING THE LEFT UPPER EXTREMITY AND LEFT SIDE OF THE TRUNK, WITH THE LEFT HAND NOTED TO BE SLIGHTLY COOL, A WARM COMPRESS WAS APPLIED. ULTRASOUND DEMONSTRATED A LINEAR HYPERECHOIC FINDING WITHIN THE LEFT BRACHIAL ARTERY. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823599 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 5239242 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention