BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE NEPHROSTOMY SET

    MDR report key: 6944201 · Received October 12, 2017

    Report

    Report Number
    1820334-2017-03488
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 27, 2017
    Report Date
    March 7, 2018
    Manufacturer
    COOK INC
    Product Code
    GBO
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED AND THERE WERE NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS. THE IFU DOES STATE "PERIOD EVALUATION IS ADVISED; THE CATHETER SHOULD NOT REMAIN INDWELLING MORE THAN FOUR MONTHS" AND THE DEVICE IS INTENDED FOR "PERCUTANEOUS DRAINAGE IN A VARIETY OF DRAINAGE APPLICATIONS (E.G. NEPHROSTOMY, BILIARY, AND ABSCESS), EITHER BY DIRECT STICK OR SELDINGER ACCESS TECHNIQUE." DUE TO THE LACK OF LOT NUMBER, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE WAS RETURNED FOR FURTHER INVESTIGATION AND IT WAS CONFIRMED THAT THE DEVICE WAS AN ULTRATHANE NEPHROSTOMY SET CATHETER. IT WAS RETURNED WITH THE PROXIMAL ASSEMBLY COMPLETELY SEPARATED FROM THE CATHETER SHAFT. THE CUSTOMER WAS CONTACTED TO DETERMINE IF THE SEPARATION OCCURRED AFTER THE CATHETER FELL OUT OF THE PATIENT OR IF THE CATHETER FELL OUT OF THE PATIENT BECAUSE THE HUB SEPARATED FROM THE CATHETER SHAFT. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THEREFORE THE FAILURE WAS LEFT AS "CATHETER FELL OUT OF PATIENT". THE ROOT CAUSE WAS TRENDED AS LIKELY PROCEDURAL RELATED DUE TO THE DEVICE REPORTEDLY BEING USED IN CONTRAINDICATION OF ITS INTENDED USE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED AND THERE WERE NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS. THE IFU DOES STATE "PERIOD EVALUATION IS ADVISED; THE CATHETER SHOULD NOT REMAIN INDWELLING MORE THAN FOUR MONTHS" AND THE DEVICE IS INTENDED FOR "PERCUTANEOUS DRAINAGE IN A VARIETY OF DRAINAGE APPLICATIONS (E.G. NEPHROSTOMY, BILIARY, AND ABSCESS), EITHER BY DIRECT STICK OR SELDINGER ACCESS TECHNIQUE." DUE TO THE LACK OF LOT NUMBER, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE WAS RETURNED FOR FURTHER INVESTIGATION AND IT WAS CONFIRMED THAT THE DEVICE WAS AN ULTRATHANE NEPHROSTOMY SET CATHETER. IT WAS RETURNED WITH THE PROXIMAL ASSEMBLY COMPLETELY SEPARATED FROM THE CATHETER SHAFT. THE CUSTOMER WAS CONTACTED TO DETERMINE IF THE SEPARATION OCCURRED AFTER THE CATHETER FELL OUT OF THE PATIENT OR IF THE CATHETER FELL OUT OF THE PATIENT BECAUSE THE HUB SEPARATED FROM THE CATHETER SHAFT. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THEREFORE THE FAILURE WAS LEFT AS "CATHETER FELL OUT OF PATIENT". THE ROOT CAUSE WAS TRENDED AS LIKELY PROCEDURAL RELATED DUE TO THE DEVICE REPORTEDLY BEING USED IN CONTRAINDICATION OF ITS INTENDED USE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, WHEN IN USE IN AN INTENSIVE CARE UNIT, IT WAS NOTED THAT THE MAC-LOC / ULTRATHANE GASTRIC DRAINAGE CATHETER FELL OUT OF THE PATIENT. ANOTHER CHEST TUBE WAS PLACED, AND PLEURODESIS WAS CONDUCTED TO PULL OUT ALL NEEDED FLUID. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE LEADING UP TO THE DISCONNECTION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725784 ULTRATHANE NEPHROSTOMY SET GBO COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention