BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER PLUS NEEDLE

    MDR report key: 3760968 · Received April 10, 2014

    Report

    Report Number
    2183502-2014-00199
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    January 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K021999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS USED WITH PATIENT AND THEN REMOVED FROM USE. ACCORDING TO REPORTER, THE NURSE HAD RETRACTED THE NEEDLE INTO THE SAFETY POSITION, BUT THE NEEDLE REMAINED EXPOSED. THE NURSE SUSTAINED A NEEDLE STICK INJURY FROM THE EXPOSED NEEDLE. IT IS BELIEVED THAT THE NURSE IS BEING TREATED IN MANNER CONSISTENT WITH THE HOSPITAL'S INTERNAL PROTOCOL FOR NEEDLE-STICK INJURIES. NO PERMANENT ADVERSE EFFECTS TO USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216159 GRIPPER PLUS NEEDLE FPA-SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL 21-2767 33X781

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other