BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER

    MDR report key: 2982928 · Received February 22, 2013

    Report

    Report Number
    2026095-2013-00034
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE CATHETER SAMPLE WILL NOT BE RETURNED TO I-FLOW FOR EVALUATION AND INVESTIGATION. RESULTS: LOT NUMBER AND MODEL INFORMATION WERE NOT REPORTED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. CONCLUSIONS: I-FLOW HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE PHYSICIAN. AT THE TIME OF THIS REPORT THE PATIENT REFUSED TO PROVIDE FURTHER INFORMATION. THE PHYSICIAN HAS NOT RETURNED ANY REQUEST FROM I-FLOW. ALTHOUGH THE SAMPLE WILL NOT BE RETURNED, AT THIS TIME AN EVENT IS OPEN TO FURTHER INVESTIGATE THE FAILURE MODE "CATHETER BREAK" (B)(4). I-FLOW PROVIDES "CAUTIONS" IN IT'S DFU WHICH STATE THE FOLLOWING: CAUTIONS: IF RESISTANCE IS ENCOUNTERED OR CATHETER STRETCHES, STOP. CONTINUED PULLING COULD BREAK THE CATHETER. IT'S ADVISABLE TO WAIT 30 TO 60 MINUTES AND TRY AGAIN. THE PATIENT'S BODY MOVEMENTS MAY RELIEVE THE CATHETER TO ALLOW EASIER REMOVAL. IF CATHETER IS STILL DIFFICULT TO REMOVE, AN X-RAY IS RECOMMENDED. DO NOT CUT OR FORCEFULLY REMOVE CATHETER. AFTER REMOVAL, CHECK DISTAL END OF CATHETER FOR BLACK MARKING TO ENSURE ENTIRE CATHETER WAS REMOVED.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: HERNIA SURGERY, CATHPLACE: UNKNOWN. PATIENT CALLED TO REPORT THAT THE DOCTOR REMOVED HER DUAL ON-Q PUMP AND CATHETERS YESTERDAY ((B)(6) 2013). STATED ONE CATHETER CAME OUT EASILY AND THE OTHER CATHETER SHE THOUGHT CAME OUT AS WELL. HOURS AFTER RETURNING HOME, HER DOCTOR CALLED AND STATED THAT HE REALIZED ONE CATHETER HAD BROKEN. HE STATED TO HER THAT ABOUT 1/2 INCH IS REMAINING INSIDE HER. ADDITIONAL INFORMATION RECEIVED: ((B)(6) 2013) IT WAS REPORTED THAT THE PATIENT'S SURGEON HAS SPOKEN TO THE PATIENT REGARDING NO NEED TO REMOVE CATHETER THE RETAINED CATHETER REMNANT UNLESS IT CAUSES PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77864 CATHETER CATHETER BSO I-FLOW, LLC UNKNOWN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR