BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTRAOSSEOUS NEEDLE SET KIT 25MM

    MDR report key: 11532334 · Received March 19, 2021

    Report

    Report Number
    3006260740-2021-00910
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 11, 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 A LEAKING EXTENSION TUBE CONNECTION WAS CONFIRMED; HOWEVER, THE ROOT CAUSE WAS NOT IDENTIFIED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE SEGMENT OF DIGITAL VIDEO DEPICTING AN INTRAOSSEOUS (IO) NEEDLE EXTENSION SET. THE DEPICTED EXTENSION SET WAS CONNECTED TO AN IMPLANTED IO NEEDLE AND A SYRINGE. THE SAMPLE APPEARED TO BE ASPIRATED. FOLLOWING ASPIRATION, LEAKAGE WAS OBSERVED AT THE SYRINGE/EXTENSION TUBE CONNECTION. WHILE LEAKAGE APPEARED TO BE EVIDENT IN THE PROVIDED VIDEO, INSPECTION OF THE VIDEO WAS INSUFFICIENT TO IDENTIFY THE CAUSE OF THE LEAKAGE. CONSEQUENTLY THIS COMPLAINT IS CONFIRMED AS ¿CAUSE UNKNOWN¿ AT THIS TIME. POTENTIAL CONTRIBUTING FACTORS INCLUDE FEMALE LUER DAMAGE AND SYRINGE/TUBING INCOMPATIBILITY. 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. THERE WAS SALINE AND BLOOD LEAKING FROM THE HUB/EXTENSION SET CONNECTION. THE CUSTOMER TIGHTENED THE EXTENSION SET AS MUCH AS POSSIBLE, WITH NO CHANGE. THE CUSTOMER THEN ATTACHED ANOTHER ICU MEDICAL EXTENSION SET, AND NOTICED AIR BUBBLES IN THE LINE AS THE EXTENSION SET WOULDN'T CORRECTLY ATTACH TO THE IO NEEDLE HUB." ADD INFO RCVD 03/03/2021: PLACEMENT DATE (B)(6) 2021. PLACEMENT INFO: 25MM. WAS THERE PATIENT HARM REPORTED?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429057 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