BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER MICRO NEEDLE

    MDR report key: 2160506 · Received July 1, 2011

    Report

    Report Number
    2183502-2011-00509
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 22, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FPA
    PMA / PMN Number
    K072059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THE PT WAS RECEIVING AN INFUSION VIA AN IMPLANTABLE PORTAL ACCESS SYSTEM. THE SUSPECT MEDICAL DEVICE WAS TO BE UTILIZED AS THE NEEDLE. WHILE ATTEMPTING TO INSERT THE CANNULA OF THE NEEDLE INTO THE PORTAL OF THE ACCESS SYSTEM, THE CLINICIAN ENCOUNTERED DIFFICULTY. THE REPORTER DESCRIBED THE INCIDENT AS "ATTEMPTING TO ACCESS IV AD, NEEDLE DEVICE SPRANG OUT, NEEDLE NOT LOCKING INTO PLACE AND OUT OF NURSE'S HAND." AS A RESULT, IT WAS NOT FULLY CAPTURED IN THE SAFETY DEVICE AND WAS EXPOSED. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PT OR CLINICIAN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER MICRO NEEDLE FPA - SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-3276 255X30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PORT-A-CATH