BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    MDR report key: 3001931 · Received March 11, 2013

    Report

    Report Number
    9617494-2013-00004
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    GMS - GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK - N
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING THE ALLEN WRENCH IN THE KIT CONTAINING CC1. P1 AND THE IP2 INTRODUCER. THE REPORT WAS DESCRIBED AS FOLLOW; THE ALLEN SCREW ON THE DEPTH ADJUSTMENT COLLAR OF THE DRILL BIT IS EITHER TOO LARGE OR THE ALLEN WRENCH USED TO ADJUST THE COLLAR IS TOO SMALL. THE PROBLEM WAS FOUND PRIOR TO INSERTION IN THE PATIENT. TWO PACKAGES WERE OPENED AND BOTH HAD ISSUES WITH THE ALLEN WRENCH. THE PHYSICIAN HAD TO CALL THE BIOMEDICAL TECHNICIAN TO BRING THEIR ALLEN WRENCH SET, HAVE IT STERILIZED AND THEN USE ON THE CATHETERS. THERE WAS A DELAY OF APPROXIMATELY 45 MINUTES. EVENTUALLY, THE SURGEON WAS ABLE TO USE ONE OF THE CATHETERS AFTER THE BIOMEDICAL TECHNICIAN WAS CALLED. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101338 KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER NA GWM GMS - GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK - N 070612

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR