BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE

    MDR report key: 4230329 · Received October 22, 2014

    Report

    Report Number
    2183502-2014-00791
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K072059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVAL IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM USE WITH A PT, THE USER WAS UNABLE TO LOCK THE NEEDLE INTO THE SAFETY MECHANISM. NO ADVERSE EFFECTS TO PT OR USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670982 GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE FPA SMITHS MEDICAL MD, INC. 21-3271 34X622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK