BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7702457 · Received July 19, 2018

    Report

    Report Number
    1820334-2018-02052
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 10, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVALUATION / INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS WAS ALSO PERFORMED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE LENGTH OF THE RETURNED BALLOON CATHETER IS APPROXIMATELY 34.3 CM IN LENGTH. A FUNCTIONAL TEST DETERMINED THE BALLOON WILL NOT INFLATE. A CLOSER EVALUATION OF THE RETURNED DEVICE NOTED THE BALLOON MATERIAL APPEARS TO HAVE BURST. THE BALLOON MATERIAL HAS A SPLIT IN THE MATERIAL. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED DEVICE. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE REVIEWED AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT KNOWN. A REVIEW OF COMPLAINT HISTORY FOR THE ASSOCIATED DEVICE LOT COULD NOT BE PERFORMED WITHOUT THE COMPLAINT DEVICE LOT NUMBER. THE FOLLOWING WARNINGS AND PRECAUTIONS ARE INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): WARNINGS DO NOT USE PETROLEUM-BASED OINTMENTS OR LUBRICANTS SINCE THEY MAY DAMAGE SILICONE AND BURST BALLOONS. ALWAYS INFLATE THE BALLOON WITH A STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. PRECAUTIONS VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. WHEN INFLATING THE BALLOON, USE A LUER SYRINGE. DO NOT USE A NEEDLE. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ENSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. REFER TO THE PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. HOW SUPPLIED SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. 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. A DEFINITIVE CAUSE FOR THE BALLOON MATERIAL RUPTURING WAS NOT ABLE TO BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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

    NO NEW EVENT INFORMATION HAS BEEN RECEIVED SINCE SUBMISSION OF THE INITIAL REPORT ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K #: 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 UNIVERSA SILICONE FOLEY CATHETER FELL OUT OF THE PATIENT DURING THE NIGHT OF (B)(6) 2018. A NEW, NON-COOK FOLEY CATHETER WAS SET UP AFTER THE ALLEGED ISSUE OCCURRED. AS REPORTED, THE BALLOON WAS TESTED AND IT WAS CONCLUDED THAT IT WAS PUNCTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543628 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR