BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR NEEDLE

    MDR report key: 3835688 · Received May 21, 2014

    Report

    Report Number
    MW5036265
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 13, 2014
    Manufacturer
    COOK MEDICAL
    Product Code
    FHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PERCUTANEOUS DRAINAGE OF ADNEXAL COMPLEX COLLECTIONS THE "STYLET" FOR THE TROCAR NEEDLE WOULD NOT PULL OUT. BOTH PIECES WERE REMOVED AND ANOTHER TROCAR NEEDLE WAS UTILIZED. AGAIN THE NEEDLE WOULD NOT PULL OUT. A THIRD ATTEMPT WAS MADE WITH A TROCAR NEEDLE WITH A DIFFERENT LOT NUMBER AND NO DIFFICULTY WAS NOTED. ALL WITH THIS LOT NUMBER WERE PULLED FROM THE SHELVES AND RETURNED TO THE COMPANY FOR REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303032 TROCAR NEEDLE TROCAR NEEDLE FHP COOK MEDICAL DTN-18-20.0/G01377 4604646

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR