BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE LUMEN POYETHYLENE CENTRAL VENOUS CATHETER TRAY

    MDR report key: 2223084 · Received August 17, 2011

    Report

    Report Number
    1820334-2011-00431
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    January 25, 2011
    Report Date
    July 18, 2011
    Manufacturer
    COOK INC
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BREAKAGE NOT LISTED IN IFU. CORRECTED DATA FROM USER FACILITY REPORT. CATHETER MATERIALS ARE SUBJECT TO AN INCOMING QUALITY CONTROL (IQC) TENSILE TEST. THE 100% VERIFICATION THAT THE SURFACE OF THE CATHETER IS FREE OF DAMAGE AND EXCESSIVE BUMPS OR ROUGHNESS. THE 100% CONFIRMATION THAT DISTAL TIP/ENDHOLE DOES NOT HAVE ANY SPLITS, NICKS OR DAMAGE. APPROPRIATE DESIGN CONTROLS ACTIVITIES HAVE BEEN COMPLETED. LABEL CONTAINS GRAPHICAL SYMBOLS REQUIRING STORAGE IN A DARK, DRY AND COOL LOCATION. THE INSTRUCTIONS FOR USE (IFU) BOOKLET CONTAINS INFO ON PROPER USAGE AND MAINTENANCE. THE COMPLAINT DEVICE WAS NOT RETURNED, THUS WE CANNOT DETERMINE THE ROOT CAUSE OF THE SEPARATION AND SUBSEQUENT LEAKAGE. IT IS HYPOTHESIZE THAT THE CATHETER WAS EXPOSED TO EXCESSIVE FORCE, BUT IT CANNOT BE CONFIRMED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. BASED ON QERA, THE RISK IS CONSIDERED ACCEPTABLE AND FURTHER RISK REDUCTION ACTIVITIES ARE NOT REQUIRED.

    Description of Event or Problem · 1

    THE AREA AROUND THE WRIST ARTERIAL LINE WAS INFILTRATED. THE RN ATTEMPTED TO STOP PRESSURE BAG OF HEPARINIZED SALINE AND DISCONTINUE THE LINE. THE SUTURES WERE CUT AND THE DRESSING WAS REMOVED. THE CATHETER SLIPPED OUT AND IT WAS NOTED THAT THE CATHETER WAS NIPPED ONLY WITH THE WHITE PLASTIC BASE LEFT. THE REMAINING CATHETER WAS RETAINED IN THE BODY AND REQUIRED SURGICAL REMOVAL. PT OUTCOME IS UNK AS NOT PROVIDED BY THE RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LUMEN POYETHYLENE CENTRAL VENOUS CATHETER TRAY FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA 2564336

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R