BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER MICRO NEEDLE

    MDR report key: 3031260 · Received March 5, 2013

    Report

    Report Number
    2183502-2013-00056
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K072059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION. ACCORDING TO REPORTER, LEAKAGE WAS SEEN AROUND THE NEEDLE. THE USER REMOVED NEEDLE FROM USE AND NEEDLE BROKE OFF FROM THE REST OF THE NEEDLE HOUSING. THE NEEDLE PIECE WAS REMOVED FROM PATIENT¿S PORTAL ACCESS SYSTEM USING TWEEZERS. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94758 GRIPPER MICRO NEEDLE FPA-SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD, INC. UNK 31X1042

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK