BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7031266 · Received November 14, 2017

    Report

    Report Number
    1820334-2017-03917
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 27, 2017
    Report Date
    February 12, 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

    (B)(4). PMA/510(K) = K091767. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE UNIVERSA SILICONE FOLEY CATHETER HAS NOT BEEN RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A REVIEW OF THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS AND TRENDS WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. A REVIEW FOR ADDITIONAL COMPLAINTS RELATED TO THIS DEVICE LOT COULD NOT BE COMPLETED WITHOUT THE DEVICE LOT NUMBER. THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS DEVICE CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS; ALWAYS INFLATE THE BALLOON WITH A STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. REFER TO THE PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. 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. 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 DEFINITIVE ROOT CAUSE 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.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED THAT THE NURSES OF AN EXTENDED CARE SERVICE REPORTED A RECURRING PROBLEM ON THE UNIVERSA SILICONE FOLEY CATHETERS. ACCORDING TO THE NURSES, THE CATHETER FALLS OUT BECAUSE THE BALLOON IS NOT INFLATED ENOUGH. "LOOKING AT THE INSTRUCTIONS FOR USE, NOT ANY RECOMMENDATIONS ABOUT THE INFLATION OF THE BALLOON BUT THE VOLUME INDICATED SEEMS TO BE NOT ENOUGH, BECAUSE PATIENTS LOST THEIR CATHETER." THERE WAS NO PART OF THE DEVICE LEFT INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR CONSEQUENCES. MANUFACTURER REPORTS 1820334-2017-03918 HAVE BEEN FILED TO CAPTURE REPORT THAT ISSUE IS RECURRING. THE REPORTERS DID NOT IDENTIFY THE ACTUAL NUMBER OF TIMES THIS ISSUE HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809495 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1