BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 8769811 · Received July 8, 2019

    Report

    Report Number
    1820334-2019-01638
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    February 2, 2017
    Report Date
    September 4, 2019
    Manufacturer
    COOK INC
    Product Code
    EZL
    UDI-DI
    00827002532410
    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. INVESTIGATION ¿ EVALUATION. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS FOUR OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. ALL COMPLAINTS ARE RELATED TO THIS COMPLAINT AS THEY ARE THE SAME FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: - DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. PRECAUTIONS. - WHEN INFLATING THE BALLOON, USE A LUER SYRINGE. DO NOT USE A NEEDLE. -REFER TO THE PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. INSTRUCTIONS FOR USE-URETHRAL INSERTION: 3. USE THE SYRINGE TO FILL THE BALLOON. IT IS RECOMMENDED THE BALLOON'S FLUID VOLUME BE CHECKED PERIODICALLY AND THEN REINFLATE WITH RECOMMENDED VOLUME. NO UNIVERSA SILICONE FOLEY CATHETER WAS RETURNED REGARDING THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY MANUFACTURING ANOMALIES. THE CAUSE FOR THIS OCCURRENCE COULD NOT BE DETERMINED.THE COMPLAINT IS CONFIRMED UPON CUSTOMER TESTIMONY. 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. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED 08 JUL 2019.

    Additional Manufacturer Narrative · 1

    PMA/510K #: 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 LESS THAN 24 HOURS AFTER HAVING A UNIVERSA SILICONE FOLEY CATHETER PLACED, THE BALLOON BURST AND THE CATHETER CAME OUT ON ITS OWN. ANOTHER CATHETER HAD TO BE PLACED. THE TYPE OF CATHETER WAS CHANGED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. ADDITIONAL DETAILS REGARDING THE PATIENT AND THE EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561513 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC G53241 7144146 00827002532410

    Patients

    Seq Age Sex Outcome Treatment
    1