BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7739271 · Received August 1, 2018

    Report

    Report Number
    1820334-2018-02187
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    June 29, 2018
    Report Date
    November 1, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. NO PHOTOS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF QUALITY CONTROL DATA AND SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY ON THE COMPLAINT DEVICE LOT COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. BASED ON THE INFORMATION AVAILABLE NO CONCLUSION CAN BE DRAWN. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE COOK PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

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

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN LEVELS ARE TAKEN (EVERY HOUR), I NOTICED THERE WAS LESS URINE THAN IN THE PREVIOUS HOUR. WHEN I VERIFIED THE TUBING, I NOTICED THAT IT WAS COMPLETELY BROKEN ABOVE THE Y, (LEVEL) TO WHICH WE INFLATE (THE BALLOON IS ALMOST ENTIRELY OUT OF THE ¿). URINE WAS PRESENT IN THE TUBING. THE UNIVERSA SILICONE FOLEY CATHETER WAS REMOVED FROM PATIENT AND A NEW CATHETER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581209 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1