BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7342749 · Received March 15, 2018

    Report

    Report Number
    1820334-2018-00596
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 13, 2018
    Report Date
    May 11, 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: THE UNIVERSA SILICONE FOLEY CATHETER HAS NOT BEEN RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND SPECIFICATIONS WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. A REVIEW FOR ADDITIONAL COMPLAINTS RELATED TO THIS DEVICE LOT COULD NOT BE COMPLETED WITHOUT THE DEVICE LOT NUMBER. THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS DEVICE CONTAINS THE FOLLOWING INSTRUCTIONS. URETERAL INSERTION ENSURE THE CATHETER IS WELL LUBRICATED THEN PASS THE DEFLATED CATHETER THROUGH THE URETHRA AND INTO THE BLADDER. AN OPEN-ENDED CATHETER MAY BE INTRODUCED OVER A WELL LUBRICATED WIRE GUIDE TO FACILITATE PLACEMENT. ONCE POSITION IS CONFIRMED (VIA FLOW OF URINE OR ASPIRATION OF URINE, IF NECESSARY), CONNECT A SYRINGE CONTAINING STERILE MEDIA TO THE LUER OF THE INFLATION LUMEN ON THE TWO- OR THREE-PRONGED Y-FITTING. USE THE SYRINGE TO FILL THE BALLOON. IT IS RECOMMENDED THE BALLOON'S FLUID VOLUME BE CHECKED PERIODICALLY AND THEN REINFLATED WITH RECOMMENDED VOLUME. SUPRAPUBIC PLACEMENT ENSURE THE CATHETER IS WELL LUBRICATED THEN PASS THE DEFLATED CATHETER THROUGH THE URETHRA AND INTO THE BLADDER. AN OPEN-ENDED CATHETER MAY BE INTRODUCED OVER A WELL LUBRICATED WIRE GUIDE TO FACILITATE PLACEMENT. ONCE POSITION IS CONFIRMED (VIA FLOW OF URINE OR ASPIRATION OF URINE, IF NECESSARY), CONNECT A SYRINGE CONTAINING STERILE MEDIA TO THE LUER OF THE INFLATION LUMEN ON THE TWO- OR THREE-PRONGED Y-FITTING. USE THE SYRINGE TO FILL THE BALLOON. IT IS RECOMMENDED THE BALLOON'S FLUID VOLUME BE CHECKED PERIODICALLY AND THEN REINFLATED WITH RECOMMENDED VOLUME. 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 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.

    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 FEMALE PATIENT WAS FITTED WITH A UNIVERSA SILICONE FOLEY CATHETER ON THE MORNING OF (B)(6) 2018 WHILE IN HER HOME. ON (B)(6) 2018 IN THE MORNING, THE CATHETER WAS FOUND IN THE PATIENT¿S BED; THE BALLOON DEFLATED. A SECOND UNIVERSA SILICONE FOLEY CATHETER WAS FITTED IN THE PATIENT AT ONCE. THE SECOND FOLEY CATHETER FELL OUT AGAIN DURING THE NIGHT OF (B)(6) 2018. THE BALLOON HAD DEFLATED. ANOTHER MANUFACTURER'S DEVICE WAS PLACED. THE PATIENT WOULD NOT ALLOW THE CUSTOMER TO HAVE THE DEVICE. 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. THIS MANUFACTURER REPORT CAPTURES THE FIRST REPORTED BALLOON DEFLATION AND THE SECOND DEFLATED BALLOON IS CAPTURED IN MFR. REPORT # 1820334-2018-00597.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185733 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1