BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7806484 · Received August 22, 2018

    Report

    Report Number
    1820334-2018-02435
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 30, 2018
    Report Date
    October 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. (B)(4). INVESTIGATION ¿ EVALUATION VISUAL EXAMINATION AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT WAS PERFORMED. ADDITIONALLY, A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND SPECIFICATIONS WAS CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED, AND A LEAK WAS NOTED IN THE PROXIMAL BOND. THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE REVIEWED AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED. A REVIEW OF COMPLAINTS FOR THE COMPLAINT DEVICE LOT COULD NOT BE COMPLETED WITHOUT THE DEVICE LOT NUMBER. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: WARNINGS - DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. PRECAUTIONS - REFER TO THE PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. - SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ENSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. ANALYSIS SHOWED THE RETURNED UNIVERSA SILICONE FOLEY CATHETER HAD A LEAK AT THE BOND BETWEEN THE BALLOON AND CATHETER MATERIAL. THE DEVICE DID NOT MEET SPECIFICATIONS. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE COMPLAINT WAS CONFIRMED BASED UPON EVALUATION OF THE RETURNED DEVICE. THE CAUSE OF THE MALFUNCTION COULD NOT BE DETERMINED. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 30AUG2018: A NEW FOLEY CATHETER WAS PLACED TO REPLACE THE FOLEY CATHETER THAT HAD FALLEN OUT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510K # K091767. (B)(4). 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, AT A PATIENTS HOME, THE UNIVERSA SILICONE FOLEY CATHETER FELL OF THE PATIENT AND WAS FOUND ON THE GROUND AFTER THE PATIENT WAS PUT INTO BED. AS REPORTED, UPON EXAMINATION, THE BALLOON WAS DEFLATED AND A LEAK WAS FOUND JUST UNDER THE BALLOON. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647172 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR