BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7285855 · Received February 21, 2018

    Report

    Report Number
    1820334-2018-00222
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 13, 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. A VISUAL EXAMINATION NOTED THE RETURNED DEVICE BALLOON MATERIAL IS SPLIT. THE DEVICE HAS AN OVER INFLATED APPEARANCE CAUSING THE BALLOON TO 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. BASED ON THE PROVIDED INFORMATION IT IS FEASIBLE TO SUGGEST THE FAILURE IS RELATED TO PRODUCT USE OR HANDLING. THE PRODUCT RECEIVED EXCESSIVE PRESSURE. 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 THE PATIENT WHO HAS ALSO HAS A JJ CATHETER, HAD TO HAVE THREE (3) INDWELLING CATHETERS WITHIN 24 HOURS. WHEN USING THE LAST TWO (2) UNIVERSA SILICONE FOLEY CATHETERS, THE BALLOON WAS PIERCED EACH TIME SO IT DIDN¿T STAY IN PLACE AND THE FOLEY CATHETER HAD TO BE CHANGED EACH TIME. THERE WAS NO PART OF THE DEVICE LEFT INSIDE THE PATIENT¿S BODY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR CONSEQUENCES.ASSOCIATED WITH (B)(4) (MDR #1820334-2018-00223).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128205 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1