BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 6315962 · Received February 9, 2017

    Report

    Report Number
    1820334-2017-00182
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    January 19, 2017
    Report Date
    January 20, 2017
    Manufacturer
    COOK INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWINGS, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS, AND THAT THE DEVICE MEETS THE NEEDS OF THE USER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS FAILURE MODE. .

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED FOR A RIGHT LUNG THERAPEUTIC TAP OF A TERMINALLY ILL PATIENT. THE REPORTING NURSE OBSERVED LEAKAGE AT THE JUNCTION OF THE CATHETER AND EXTERNAL HUB FOLLOWING PLACEMENT OF THE DEVICE. THE PATIENT REFUSED A DEVICE REPLACEMENT AGAINST MEDICAL ADVICE ( AMA) TO PRECLUDE POSSIBLE INFECTION. THE ATTENDING NURSE APPLIED TEGADERM TO SEAL OFF THE LEAK. THE ATTENDING NURSE ADVISED THAT THE "DRAIN IS MOST LIKELY TO BE REMOVED WITHIN THE NEXT COUPLE OF DAYS." NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102253 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1