BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 911656 · Received September 10, 2007

    Report

    Report Number
    2026095-2007-00043
    Event Type
    Other
    Date Received
    September 10, 2007
    Date of Event
    May 1, 2007
    Report Date
    August 8, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS RECEIVED AND EVALUATED. NO LOT NUMBER WAS AVAILABLE. THE CATHETER WAS RECEIVED IN TWO PIECES (I-FLOW PART NUMBER 4000948). VISUAL EXAMINATION SHOWED THAT THE MID-BODY AND THE BREAKING POINT OF THE CATHETER WERE OVERSTRETCHED. THE MEASUREMENTS OF THE COMPONENTS FOUND THEM TO BE LONGER THAN THE DRAWING DIMENSIONS. THE DEVICE DIRECTIONS FOR USE (DFU) STATE: "IF RESISTANCE IS ENCOUNTERED OR CATHETER STRETCHES, STOP. CONTINUED PULLING COULD BREAK THE CATHETER. IT'S ADVISABLE TO WAIT 30-60 MINUTES AND TRY AGAIN. THE PATIENT'S BODY MOVEMENTS MAY RELIEVE THE CATHETER TO ALLOW EASIER REMOVAL" "IF THE CATHETER IS STILL DIFFICULT TO REMOVE, AN X-RAY IS RECOMMENDED" "DO NOT CUT OR FORCEFULLY REMOVE THE CATHETER" "DO NOT APPLY ADDITIONAL TENSION IF THE CATHETER BEGINS TO STRETCH" BASED ON THE EVALUATION AND INFORMATION PROVIDED IN THE DEVICE'S DFU'S, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. NO FURTHER INVESTIGATION WILL BE CONDUCTED AS NO MALFUNCTION OF THE DEVICE WAS IDENTIFIED. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    CATHETER SNAPPED WHEN BEING REMOVED BY PHYSICIAN. CATHETER END WAS SURGICALLY REMOVED AND PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP MEB I-FLOW CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other