BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLONG CATHETER

    MDR report key: 3251769 · Received June 21, 2013

    Report

    Report Number
    1625424-2013-00001
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 28, 2013
    Report Date
    June 21, 2013
    Manufacturer
    LIFE-TECH, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K001129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND NO LOT NUMBER INFO WAS PROVIDED NOR SPECIFIC PT INFO AND DATES. CONTACTED DISTRIBUTION FOR FURTHER INFO NEEDED TO CONDUCT A THOROUGH INVESTIGATION. A F/U WILL BE FILED PENDING RECEIPT OF ADD'L, ELABORATIVE INFO.

    Description of Event or Problem · 1

    PT RECEIVED A PERIPHERAL PAIN CATHETER SOME MONTHS AGO. AN APPROXIMATE 4CM LONG TIP OF THE CATHETER WAS TORN DURING DRAWING THE CATHETER WHICH IS STILL IN THE PT'S LEG AND IS PROBLEMATIC. THE SURGEON WAS UNABLE TO LOCALIZE THE TIP USING MRT. THE CATHETER WAS DRAWN AFTER A WEEK AND THERE WAS DE-LOCALIZATION. ACCORDING TO THE ANESTHETIST THE CATHETER SEEMED TO MAKE A LOOP AND THEREFORE GOT STUCK. THE OCCURRENCE DATE WAS THE END OF (B)(6). IT IS DIFFICULT TO SAY IF THE PAIN STARTED AT ONE OR LATER. THERE WAS AN IRRITATION OF THE TISSUE CAUSED BY THE MANY CATHETERS AND THE EXACT PLACE OF THE CATHETERS WAS INSENSITIVE. AFTER THE NEW CATHETERS WERE IMPLEMENTED SHE FELT THE PAIN. THERE IS NO INFLAMMATORY REACTION OF THE TISSUE BUT A SHARP PAIN IN THE DISTAL THIGH UNDER STRESS. THE COMMENTS ABOVE HAVE NOT BEEN INDEPENDENTLY VERIFIED BY THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282942 PROLONG CATHETER ANESTHESIA CONDUCTION KIT CAZ LIFE-TECH, INC. 18/050/PLT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention