BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXOLONG SPECIAL SPROTTE SET ACC. MEIER

    MDR report key: 745702 · Received August 4, 2006

    Report

    Report Number
    9611612-2006-00004
    Event Type
    Other
    Date Received
    August 4, 2006
    Date of Event
    July 21, 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    WE ASSUME THAT DURING THE INSTALLATION, THE CATHETER WAS RETRACTED AGAINST THE CUTTING EDGE OF THE CANNULA TIP AND A PIECE OF THE CATHETER WAS CUT OFF.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

    A PLEXOLONG CATHETER WAS INSTALLED AT 2006, AND REMOVED FOUR DAYS LATER. AFTER THE REMOVAL, THE PHYSICIAN RECOGNIZED THAT THERE WERE 12 CENTIMETERS OF THE CATHETER MISSING. WE ASKED FOR MORE INFO AND DETAILS, BUT THIS INFO HASN'T ARRIVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXOLONG SPECIAL SPROTTE SET ACC. MEIER * BSP PAJUNK GMBH 511151-31A 654

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR