BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 961449 · Received November 30, 2007

    Report

    Report Number
    2523676-2007-00099
    Event Type
    Other
    Date Received
    November 30, 2007
    Date of Event
    September 7, 2007
    Report Date
    November 7, 2007
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MFR TO BE EVALUATED AND A LOT NUMBER WAS NOT PROVIDED. WITHOUT THE ACTUAL SAMPLE OR A LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR, B. BRAUN MEDICAL INDUSTRIES. IF THE ACTUAL DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PT WAS ADMITTED TO THE HOSP TO RULE OUT SEPSIS. HIS HOSP COURSE WAS UNCOMPLICATED. HIS BLOOD CULTURES, CEREBROSPINAL FLUID CULTURE, AND URINE CULTURE WERE ALL NEGATIVE. WHILE PREPARING PT FOR DISCHARGE TO HOME, THE INTRAVENOUS (IV) ACCESS WAS DISCONTINUED, HOWEVER, WHEN IT WAS DISCONTINUED A PIECE OF THE IV CATHETER BROKE OFF AND STAYED WITHIN THE VEIN OF THE SCALP. SURGERY WAS ALERTED AND EVALUATED THE PT. IT WAS DETERMINED THAT THE CATHETER COULD NOT BE REMOVED AND THE PT WAS SCHEDULED FOR SURGERY. A CT SCAN LOCALIZATION IDENTIFIED THE CATHETER AND THE SURGEON WAS ABLE TO REMOVE THE TIP OF THE CATHETER UNDER GENERAL ANESTHESIA. BECAUSE THE PT WAS PLACED UNDER GENERAL ANESTHESIA, HE WAS KEPT OVERNIGHT FOR OBSERVATION. THE PT WAS DISCHARGED HOME IN A STABLE CONDITION. THE PRODUCT WAS RETAINED. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE INFANT SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT. THE LOT NUMBER REMAINS UNK. THE PRODUCT CODE IS 4252500. THE SAMPLE IS BEING RETAINED BY THE RISK MGMT DEPT AT THIS TIME. HOWEVER, IT HAS BEEN REPORTED THAT THE SAMPLE WILL POSSIBLY BE SENT 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 1 MO Other