BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTRAOSSEOUS NEEDLE SET KIT 25MM

    MDR report key: 11532337 · Received March 19, 2021

    Report

    Report Number
    3006260740-2021-00911
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 21, 2021
    Report Date
    March 1, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FMI
    UDI-DI
    00801741163678
    PMA / PMN Number
    K191976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF LEAKAGE WHEN FLUSHING THE INTRAOSSEOUS (IO) NEEDLE WAS CONFIRMED; HOWEVER, THE ROOT CAUSE WAS NOT IDENTIFIED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE SEGMENT OF DIGITAL VIDEO DEPICTING AN IO NEEDLE EXTENSION SET. THE DEPICTED EXTENSION SET WAS CONNECTED TO AN IMPLANTED IO NEEDLE. THE EXTENSION SET WAS BEING FLUSHED AND INITIALLY BLOOD AND THEN CLEAR INFUSATE WAS VISIBLE LEAKING FROM THE CONNECTION SITE BETWEEN THE EXTENSION TUBE AND THE IO NEEDLE. WHILE LEAKAGE AT THE CONNECTION BETWEEN THE EXTENSION SET AND IO NEEDLE WAS EVIDENT IN THE SUPPLIED VIDEO, INSPECTION OF THE VIDEO WAS INSUFFICIENT TO IDENTIFY THE CAUSE. POTENTIAL CONTRIBUTING FACTORS INCLUDE EXTENSION SET DAMAGE AND IO NEEDLE LUER DAMAGE. A LOT HISTORY REVIEW (LHR) OF 123306 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (123306) HAVE BEEN REPORTED FROM THE SAME FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED "CUSTOMER INSERTED IO NEEDLE, AND ATTACHED EXTENSION SET. WHEN FLUSHING THE CUSTOMER NOTICED BLOOD/SALINE LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422408 BD INTRAOSSEOUS NEEDLE SET KIT 25MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI C.R. BARD, INC. (BASD) -3006260740 N/A 123306 00801741163678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other