BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3965952 · Received July 3, 2014

    Report

    Report Number
    3965952
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN FOUR KNOWN INSTANCES WHEN THE NEEDLE BENT AS THE NURSE WAS ATTEMPTING TO ACCESS THE PORTACATH. THE NEEDLE IS CURRENTLY DISTRIBUTED BY SMITH'S MEDICAL, BUT WAS FORMERLY DELTEC. THE NURSES DESCRIBED THE NEEDLE AS "GIVING WAY" UPON ENTRY INTO THE PORT. THE NURSES HAVE EXPERIENCE WITH USING THE NEEDLE. THERE WAS NO PATIENT HARM IN ANY OF THE FOUR EVENTS.MANUFACTURER RESPONSE FOR BLUNT CANNULA NON CORING SAFETY NEEDLE, GRIPPER MICRO (PER SITE REPORTER).======================THE SMITHS MEDICAL REP CAME IMMEDIATELY TO THE FACILITY TO MEET WITH TEAM, AND ASSISTED STAFF WITH REPLACEMENT OF THIS NEEDLE LOT 34X136. THIS WAS DIFFICULT AS THIS NEEDLE IS PART OF A PORT ACCESS KIT WHICH IS ASSEMBLED BY MEDICAL ACTION INDUSTRIES, INC. THESE KITS ALSO HAD TO BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391984 * PORT ACCESS, KIT LRS MEDICAL ACTION INDUSTRIES, INC * 187966

    Patients

    Seq Age Sex Outcome Treatment
    1 * NON-CORING SAFETY NEEDLE, CATALOG 21-3277-24,| THE PORT ACCESS KITS.| SMITH'S MEDICAL GRIPPER MICRO BLUNT CANNULA,| LOT #34X136, EXPIRATION: 02/01/2019 -THE NEEDLE IN