BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTRAOSSEOUS NEEDLE SET KIT

    MDR report key: 13736061 · Received March 11, 2022

    Report

    Report Number
    3006260740-2022-00736
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 17, 2022
    Report Date
    April 19, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FMI
    UDI-DI
    00801741163586
    PMA / PMN Number
    K203193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF DIFFICULT INFUSION WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT INFUSION THROUGH THE 90° LUER ADAPTOR OF THE EXTENSION SET COULD BE INHIBITED IF THE CONNECTING DEVICE IS ADVANCED PAST THE INTENDED STOP REGION OF THE ADAPTOR. INITIAL INVESTIGATION INDICATED THAT THIS CIRCUMSTANCE ONLY OCCURS WITH OVERTIGHTENING OF SOME INTERFACING DEVICES AND BD IS WORKING TO ASSESS THE EXACT CIRCUMSTANCES BY WHICH THIS CAN OCCUR. THESE INVESTIGATION EFFORTS ARE ONGOING AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF 123307 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED CANNOT INFUSE THROUGH THE T CONNECTOR PORT WHEN THE SYRINGE IF FULLY THREADED ON THE CONNECTOR. IT WAS STATED THE DEVICE WAS NOT USED ON A PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED CANNOT INFUSE THROUGH THE T CONNECTOR PORT WHEN THE SYRINGE IF FULLY THREADED ON THE CONNECTOR. IT WAS STATED THE DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150867 BD INTRAOSSEOUS NEEDLE SET KIT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI C.R. BARD, INC. (BASD) -3006260740 N/A 123307 00801741163586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other