BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 1080782 · Received July 16, 2008

    Report

    Report Number
    2523676-2008-00065
    Event Type
    Other
    Date Received
    July 16, 2008
    Date of Event
    May 6, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT YET BEEN RETURNED TO THE MFR TO BE EVALUATED AND A LOT NUMBER WAS NOT REPORTED. WITHOUT THE SAMPLE AND A LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED. THERE ARE GENERALLY TWO CAUSES FOR THIS TYPE OF INCIDENT. FIRST, WHILE INSERTING THE CATHETER INTO THE VESSEL, THE NURSE MAY RE-CANNULATE THE STYLET NEEDLE THROUGH THE I.V. OF THE CATHETER AND PERFORATE THE WALL OF THE CATHETER CAUSING A FRACTURE. THE INSTRUCTIONS FOR USE SUPPLIED WITH THE INTROCAN SAFETY STATE THE FOLLOWING: "AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM." SECONDLY, WHEN REMOVING THE TAPE AND / OR DRESSING FROM THE CATHETER INSERTION SITE, A NURSE MAY USE SCISSORS AND INADVERTENTLY CUT THE CATHETER. NEITHER OF THESE PRACTICES, RE-CANNULATING OR USING SCISSORS IN THE AREA OF A CATHETER, ARE RECOMMENDED PRACTICES. WITHOUT THE SAMPLE FOR EVAL, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, B. BRAUN MEDICAL INDUSTRIES.

    Description of Event or Problem · 1

    AS REPORTED ON THE MEDWATCH FORM: "ANESTHESIA PLACED THIS 14G NEEDLE DURING SURGERY. WHEN THE PT ARRIVED ON HER FLOOR, SHE WAS COMPLAINING OF DISCOMFORT IN HER ARM. THE NURSE REMOVED THE CATHETER FROM THE LEFT ANTECUBITAL VEIN, AND SHE NOTICED THAT THE CATHETER WAS NOT INTACT AND A PORTION OF THE CATHETER REMAINED IN THE PT. THE REMAINING PORTION OF THE CATHETER WAS REMOVED DURING A BEDSIDE PROCEDURE. THE REP WILL COME TO THE HOSP NEXT WEEK TO RETRIEVE THE CATHETER." DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? REMOVAL OF I.V. CATHETER. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOP WORKING. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE CATHETER FRAGMENT WAS REMOVED WITHOUT INCIDENT. THE LOT NUMBER REMAINS UNK SINCE THE CATHETER WAS PLACED IN THE OR. THE SAMPLE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other