BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7218043 · Received January 25, 2018

    Report

    Report Number
    1820334-2018-00080
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 10, 2018
    Report Date
    April 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

    INVESTIGATION EVALUATION: A REVIEW OF THE MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND SPECIFICATIONS WAS PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTED THE INFLATION LUMEN IS MISSING ON THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD FOR COMPLAINT DEVICE COULD NOT BE PERFORMED AS THE LOT INFORMATION WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY RECORDS FOR ADDITIONAL COMPLAINTS RELATED TO THIS DEVICE LOT ALSO COULD NOT BE PERFORMED AS THE LOT INFORMATION WAS NOT PROVIDED. 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 FOR THE REPORTED ISSUE 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.

    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 SEVERAL INCIDENTS HAVE OCCURRED WITH THREE PATIENTS THAT HAD THE UNIVERSA SILICONE FOLEY CATHETER PLACED IN THEM. AS REPORTED, THE CATHETER WAS FOUND IN THEIR BED WITH THE INFLATION NOZZLE SECTIONED. THERE WAS NO LOT NUMBER FOUND BECAUSE THE PACKAGING WAS BINNED THE DAY BEFORE. ADDITIONAL INFORMATION WAS PROVIDED TO CLARIFY IT WAS EXTREMITY OF FOLEY WHICH WAS SECTIONED. "IT MEANS THE PART OF THE FOLEY OUTSIDE OF THE PATIENT. WHERE WE INSERT THE SYRINGE TO INFLATE. THEY HAD TO REPLACE THE FOLEY CATHETER WITH ANOTHER ONE. YOU WILL RECEIVE THE PRODUCT, BECAUSE THE PICK-UP HAS BEEN DONE." THERE WAS NO PART OF THE DEVICE LEFT INSIDE THE PATIENT¿S BODY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR CONSEQUENCES DUE TO THE OCCURRENCE. MANUFACTURER REPORTS 1820334-2018-00080 (1ST PATIENT), 1820334-2018-00081 (2ND PATIENT) AND 1820334-2018-00082 (3RD PATIENT) HAVE BEEN FILED TO CAPTURE EACH OF THE THREE PATIENTS REPORTED TO HAVE EXPERIENCED THE SAME PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62198 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1