BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXOLONG SPEZIAL SET ACC. MEIER

    MDR report key: 745716 · Received August 4, 2006

    Report

    Report Number
    9611612-2006-00003
    Event Type
    Other
    Date Received
    August 4, 2006
    Date of Event
    February 13, 2006
    Report Date
    August 4, 2006
    Manufacturer
    PAJUNK GMBH
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ASSUME THAT DURING THE INSTALLATION THE CATHETER WAS RETRACTED AGAINST THE CUTTING EDGE OF THE CANNULA TIP AN A PIECE OF THE CATHETER WAS CUT OFF. IN ORDER TO PREVENT SUCH USER ERRORS WE HAVE A WARNING NOTICE IN OUR OPERATING INSTRUCTIONS FOR THESE PRODUCTS: "PLEASE OBSERVE: DO NOT RETRACT THE CATHETER (BE IT WITH OR WITHOUT INSERTED MANDRIN) BACK AGAINST THE CUTTING EDGE OF THE CANNULA TIP, SINCE OTHERWISE A PART OF THE CATHETER MAY BE CUTT OFF." (SEE OPERATING INSTRUCTIONS ATTACHED).

    Description of Event or Problem · 1

    WE WERE INFORMED ABOUT THIS INCIDENT IN 2006. AFTER THE REMOVAL OF AN PLEXOLONG CATHETER, THE PHYSICIAN RECOGNIZED THAT THERE WERE 6 CM OF THE CATHETER MISSING. A SECOND SURGICAL INTERVENTION WAS NECESSARY TO SEARCH FOR THE MISSING PART OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXOLONG SPEZIAL SET ACC. MEIER * BSP PAJUNK GMBH 521151-31A 654

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention