BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIPPER PLUS NEEDLE

    MDR report key: 1231824 · Received November 11, 2008

    Report

    Report Number
    2183502-2008-00336
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    March 22, 2008
    Report Date
    November 11, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: 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

    INFORMATION WAS RECEIVED THAT REPORTED A NEEDLESTICK INCIDENT THAT OCCURRED 2008. REPORTEDLY DURING DEACCESS THE NURSE FELT THAT THE NEEDLE WAS "STUCK" AND FORCIBLY PULLED BACK ON IT. THE NEEDLE REBOUNDED AND THE NURSE HAD A NEEDLESTICK. THE REPORTER DOES NOT BELIEVE THAT THE NURSE ACTIVATED THE SAFETY DEVICE. THE NURSE DID HAVE ADDITIONAL IN-VITRO TESTING AND AN INJECTION OF GAMMA-GLOBULIN PER THEIR PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRIPPER PLUS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FMI SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-2768 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention