BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7905662 · Received September 25, 2018

    Report

    Report Number
    1820334-2018-02832
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 6, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    UDI-DI
    00827002172036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. FUNCTION TESTING DETERMINED THE BALLOON INFLATED WITHOUT ISSUE. THERE WERE NO LEAKS IN THE BALLOON MATERIAL. DURING DEFLATION OF THE BALLOON THE INFLATION VALVE SEPARATED FROM THE HUB. THE DEVICE HISTORY RECORD REVIEW SHOWED THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED FAILURE. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT FOR COMPLAINT DEVICE LOT NUMBER 8333411. INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTION: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. A FUNCTIONAL TEST DETERMINED THE RETURNED FOLEY CATHETER INFLATED WITHOUT ISSUE. DURING DEFLATION OF THE BALLOON, THE INFLATION VALVE SEPARATED FROM THE HUB. THE CAUSE OF INFLATION VALVE SEPARATION COULD NOT BE DETERMINED. IT IS POSSIBLE EXCESSIVE FORCE APPLIED TO THE INFLATION VALVE CAUSED SEPARATION, LEAKAGE, AND DEFLATION OF THE BALLOON. 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 CAUSE FOR THIS SPECIFIC FAILURE MODE COULD NOT BE ESTABLISHED. A QUALITY ENGINEER RISK ASSESSMENT CONCLUDED NO RISK REDUCTION ACTIVITIES ARE REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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 RECEIVED STATES THAT THE BALLOON WAS FILLED WITH 1.5ML(CC) OF LIQUID FOR PLACEMENT. THERE WERE NO MEDICAL ILLNESSES OR ADVERSE EFFECTS RELATED TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(6). THE 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 DURING THE HYPOSPADIAS REPAIR PROCEDURE, THE UNIVERSA SILICONE FOLEY CATHETER WAS INSERTED ON (B)(6) 2018 AROUND 12 NOON AND AT 9 PM THE FOLEY CATHETER CAME OUT AND BALLOON WAS DEFLATED. THE PATIENT HAD ANOTHER FOLEY CATHETER PLACED. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746992 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC NA 8333411 00827002172036

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO ASKU