BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7377045 · Received March 28, 2018

    Report

    Report Number
    1820334-2018-00476
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 23, 2018
    Report Date
    May 25, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    UDI-DI
    00827002175129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION, EVALUATION: THE UNIVERSA SILICONE FOLEY CATHETER HAS NOT BEEN RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND SPECIFICATIONS WAS CONDUCTED. DEVICES FROM THE SAME LOT IN STOCK AT THE COOK DISTRIBUTION CENTER WERE RETRIEVED FOR THE INVESTIGATION. NO ANOMALIES WERE OBSERVED WITH THESE UNUSED UNITS. THREE OF THE UNITS WERE TESTED. THE THREE DEVICES WERE INFLATED WITH 5ML OF WATER (AS INDICATED IN LABELING) AND LEFT FOR 24 HOURS INSIDE A CLOSED DARK CARDBOARD BOX. THE THREE BALLOONS WERE DEFLATED AND RE-INFLATED WITH 5ML WATER AND LEFT AGAIN FOR ANOTHER 24 HOURS. NO LEAKS WERE NOTED DURING EITHER 24-HOUR PERIOD AND THE BALLOONS REMAINED INFLATED DURING THE TEST PERIODS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW FOR ADDITIONAL COMPLAINTS RELATED TO THIS DEVICE LOT REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7991491. THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS DEVICE CONTAINS THE FOLLOWING REFERENCES: URETERAL INSERTION: ENSURE THE CATHETER IS WELL LUBRICATED THEN PASS THE DEFLATED CATHETER THROUGH THE URETHRA AND INTO THE BLADDER. AN OPEN-ENDED CATHETER MAY BE INTRODUCED OVER A WELL LUBRICATED WIRE GUIDE TO FACILITATE PLACEMENT. ONCE POSITION IS CONFIRMED (VIA FLOW OF URINE OR ASPIRATION OF URINE, IF NECESSARY), CONNECT A SYRINGE CONTAINING STERILE MEDIA TO THE LUER OF THE INFLATION LUMEN ON THE TWO- OR THREE-PRONGED Y-FITTING. USE THE SYRINGE TO FILL THE BALLOON. IT IS RECOMMENDED THE BALLOON'S FLUID VOLUME BE CHECKED PERIODICALLY AND THEN RE-INFLATED WITH RECOMMENDED VOLUME. " SUPRAPUBIC PLACEMENT: ENSURE THE CATHETER IS WELL LUBRICATED THEN PASS THE DEFLATED CATHETER THROUGH THE URETHRA AND INTO THE BLADDER. AN OPEN-ENDED CATHETER MAY BE INTRODUCED OVER A WELL LUBRICATED WIRE GUIDE TO FACILITATE PLACEMENT. ONCE POSITION IS CONFIRMED (VIA FLOW OF URINE OR ASPIRATION OF URINE, IF NECESSARY), CONNECT A SYRINGE CONTAINING STERILE MEDIA TO THE LUER OF THE INFLATION LUMEN ON THE TWO- OR THREE-PRONGED Y-FITTING. USE THE SYRINGE TO FILL THE BALLOON. IT IS RECOMMENDED THE BALLOON'S FLUID VOLUME BE CHECKED PERIODICALLY AND THEN RE-INFLATED WITH RECOMMENDED VOLUME. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION A LIKELY CAUSE FOR THE ALLEGED BALLOON DEFLATION CANNOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THE PATIENT LOST THE ABILITY TO DRAIN THEIR BLADDER UNTIL A NEW FOLEY WAS PLACED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REMOVED AND DISCARDED THEIR UNIVERSAL SILICONE FOLEY CATHETER DAYS AFTER IT WAS CHANGED AT THE CLINIC DUE TO THE BALLOON DEFLATING. A REPLACEMENT SUPRAPUBIC CATHETER WAS PLACED IN THE BLADDER WITH NO REPORTED ISSUES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221936 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC 00827002175129

    Patients

    Seq Age Sex Outcome Treatment
    1