BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC® GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE

    MDR report key: 6573147 · Received May 17, 2017

    Report

    Report Number
    3012307300-2017-01050
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 20, 2017
    Report Date
    May 17, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE CATALOG NUMBERS: 21-2965-24 AND 21-2966-24. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. 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

    IT WAS REPORTED THAT THE NEEDLE SAFETY OF A DELTEC® GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE CAME UNDONE AND WENT PAST THE PARAMETERS OF THE DEVICE. THE FAULT HAPPENED IMMEDIATELY UPON USE. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354186 DELTEC® GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1