BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7349637 · Received March 19, 2018

    Report

    Report Number
    1820334-2018-00475
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 22, 2018
    Report Date
    May 17, 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 INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND SPECIFICATIONS WAS PERFORMED. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. CHECK-IN PHOTOS SHOW ONE RETURNED CATHETER DEVICE. INVESTIGATION PHOTOS SHOW A HOLE IN THE SIDE OF THE BALLOON WITH SOME RAISED MATERIAL. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE BALLOON HAD BURST. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE COMPLAINT DEVICE COULD NOT BE PERFORMED AS THE LOT NUMBER INFORMATION WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY RECORDS FOR ADDITIONAL COMPLAINTS WAS ALSO UNABLE TO BE PERFORMED WITHOUT THE LOT NUMBER OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING RELATED INSTRUCTIONS: WARNINGS: ALWAYS INFLATE THE BALLOON WITH A STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON DIOXIDE OR ANY OTHER GAS. DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. PRECAUTIONS: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. WHEN INFLATING THE BALLOON, USE A LUER SYRINGE. DO NOT USE A NEEDLE. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ENSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. REFER TO THE PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. HOW SUPPLIED: INTENDED FOR ONE-TIME USE. STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. 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. 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. A 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. THE CAUSE OF THE REPORTED BALLOON LEAK IS DUE TO THE BALLOON BURST. THE CAUSE FOR THE BALLOON BURSTING WAS NOT ABLE TO BE DETERMINED. 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

    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 THE PATIENT WAS PLACED WITH A UNIVERSA SILICONE FOLEY CATHETER. POSSIBLY THE INLYING CATHETER WAS PULLED OUT BY THE PATIENT, THIS ONE HAVING COGNITIVE DISORDER. HOWEVER, THE BALLOON WAS LEAKING AND IT WAS IMPOSSIBLE TO INFLATE IT AGAIN AND THUS TO REPLACE THE 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. AS REPORTED, THERE ARE RECURRENT INCIDENTS IN A SHORT PERIOD OF TIME. THE CUSTOMER HAS REQUESTED A REPRESENTATIVE VISIT FOR AN ASSESSMENT AND TO REMIND THE GOOD PRACTICE FOR USE. THE REPRESENTATIVE VISITED THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FOLEYS ARE FOUND IN THE BED OF PATIENTS, BALLOON STILL INFLATED AND ALWAYS RELATED TO THE 16FR AND 18FR SIZES. THEY HAVE TO CHANGE THE FOLEY SOMETIMES 5 OR 6 TIMES JUST ON ONE PATIENT. CAUSING CONFLICT WITH THEM BECAUSE IT IS VERY UNCOMFORTABLE TO DISTURB OLD PATIENTS OR SICK PATIENTS JUST FOR CHANGING A FOLEY. SOME CUSTOMERS HAVE TO KEEP THEIR FOLEY TILL THE END OF THEIR LIFE, IT¿S UNBELIEVABLE FOR THEM TO CHANGE THE FOLEY EACH 48H. THEY ALWAYS INFLATE AT 5ML AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE FOLEY CATHETERS ARE USED IN PATIENTS FOR THE HEALING OF SACRUM WOUNDS, FOR CHRONIC DISEASES, AND FOR PATIENTS WITH NEUROLOGICAL DISEASES OR WITH ACCIDENTS AND FOR WHOM THEY NEED AN INDWELLING FOLEY. MAINLY FOR PATIENTS IN LONG AND MEDIUM STAY AND OFTEN OLDER (GERIATRIC SERVICE). THEY HAVE TO INFLATE THE 16FR AND 18TH MORE THAN 5ML, WHEN THEY TRY AT 8ML, THE BALLOON IS STAYING IN PLACE. THIS FACILITY HAS REPORTED FIVE SIMILAR EVENTS THAT HAVE BEEN CAPTURED IN MANUFACTURER REPORT NUMBERS 1820334-2018-00222, 1820334-2018-00223, 1820334-2018-00596, 1820334-2018-00597, AND 1820334-2018-00475.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191609 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1