BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 8084176 · Received November 19, 2018

    Report

    Report Number
    1820334-2018-03389
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 31, 2018
    Report Date
    December 18, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K091767. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTES THE DEVICE WAS RETURNED WITH FLUID IN THE BALLOON. THE FLUID WAS REMOVED SUCCESSFULLY FROM THE RETURNED BALLOON. FUNCTIONAL TESTING WAS PERFORMED BY INFLATING THE BALLOON WITH 30 ML OF WATER. THE BALLOON INFLATED FINE. THERE WERE NO LEAKS NOTED. THE BALLOON DEFLATED FINE, WITHOUT ISSUE. THE INFLATION VALVE WAS FOUND TO FUNCTION AS INTENDED. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED. A SEARCH OF COMPLAINT RECORDS FOR THE COMPLAINT DEVICE LOT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. PER THE INSTRUCTIONS FOR USE: HOW SUPPLIED = STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. CURRENT PROCESS AND QUALITY INSPECTION CHECKS ARE IN PLACE TO ENSURE THE FUNCTIONALLY AND DEVICE INTEGRITY PRIOR TO SHIPMENT. NO SPECIFIC ISSUE WITH THIS DOCUMENTATION WAS FOUND THAT MAY HAVE CONTRIBUTED TO THIS FAILURE MODE, AND THE COMPLAINT DEVICE WAS FOUND TO BE MANUFACTURED WITHIN SPECIFICATION. PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE FOUND NO FUNCTIONAL ABNORMALITIES. THE INVESTIGATORS WERE ABLE TO DRAIN THE REMAINING FLUID, INFLATE AND THEN DRAIN THE BALLOON WITHOUT THE BALLOON LEAKING AND NO OTHER OBSERVED ISSUES. THE BALLOON WAS ALSO INFLATED AND LEFT ALONE FOR APPROXIMATELY 2 DAYS AND NO EVIDENCE OF BALLOON DEFLATION, LEAKAGE OR LUMEN COMMUNICATION WAS OBSERVED. AS THE PATIENT ANATOMY AND THE LIVING CONDITIONS COULD NOT BE REPLICATED IN THE LAB, THE CAUSE FOR THE DEVICE MIGRATION CANNOT BE ESTABLISHED AT THIS TIME. THERE IS NO PROBLEM DETECTED FOR DEVICE FUNCTIONALITY AND THE COMPLAINT COULD NOT BE CONFIRMED. A QUALITY ENGINEER RISK ASSESSMENT CONCLUDED NO RISK REDUCTION ACTIVITIES ARE REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED, OUR DEPARTMENT OF LONG STAYS WAS NOTIFIED THAT A PATIENT PRESENTED WITH A CATHETER THAT HAD COME OUT. THE VISUAL EXAMINATION NOTED A HALF-DEFLATED BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION RECEIVED ON 29-OCT-2018: THE COOK REPRESENTATIVE HAS VISITED THE FACILITY AND EMAILED THE FOLLOWING INFORMATION. I HAVE VISITED (REDACTED) ON THURSDAY LAST WEEK. WE MET 2 NURSES. THE FOLEY CATHETERS ARE USED IN 3 DIFFERENT LOCATIONS AND THE MAJORITY OF THE COMPLAINTS ARE COMING FROM THE GERIATRIC SIDE. THOSE PATIENTS KEEP A FOLEY CATHETER UNTIL THEY PASS THE WAY. THEY HAVE A WELL DILATED URETER AND THE 5ML BALLOON ON OUR FOLEY SEEMS TO BE TOO SMALL AND THE FOLEY FALL DOWN. IT IS THE NURSES WHO ARE PLACING THE FOLEY. THEY WERE USING ANOTHER MANUFACTURER'S FOLEY CATHETER BEFORE AND THE BALLOON WAS 15ML. THEY HAVE DECIDED TO INCREASE TO 8ML ON OUR BALLOON AND HAVE ALSO PROPOSED TO BUY THE 30ML VERSION OF OUR FOLEY. ONE UROLOGIST DOESN¿T AGREE AND THEY WILL ASK TO THE SECOND ONE. THEY ARE ALSO USING THE OTHER MANUFACTURER'S FOLEY CATHETER FOR THOSE PATIENTS. THEY DON¿T HAVE ISSUE WITH URETEROSCOPY SIDE.

    Description of Event or Problem · 1

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924972 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1