BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 5086262 · Received September 17, 2015

    Report

    Report Number
    9611710-2015-00159
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 19, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: A QUALITY INVESTIGATION WAS PERFORMED. NO SAMPLES WERE RETURNED, BUT A BATCH REVIEW WAS PERFORMED ON THE LOT NUMBER PROVIDED AND THERE WERE NO SIGNS OF NON-DEFLATION DETECTED DURING THE INSPECTION. REVIEW OF THE IN-PROCESS FUNCTIONAL TEST REPORT DID NOT REVEAL ANY SIGN OF SUCH DEFECT DURING THE FUNCTIONAL TEST. THE SAMPLES TAKEN FROM THE MANUFACTURING LOT MET THE SPECIFICATION WHEN SUBJECTED TO THE FUNCTIONAL TESTS. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. THERE WAS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATIONS AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL CONTINUE TO MONITOR TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THIS COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOLEY CATHETER THAT HAD BEEN IN PLACE FOR APPROXIMATELY 8 TO 12 HOURS COULD NOT BE REMOVED BECAUSE THE BALLOON COULD NOT BE DEFLATED. THE CATHETER WAS SUBSEQUENTLY REMOVED BY INSERTING A SPINAL GUIDEWIRE THROUGH THE PATIENT'S URETHRA TO DEFLATE THE BALLOON. THEY WENT ON TO REPORT PATIENT EXPERIENCED PAIN DURING THE PROCEDURE THAT REQUIRED THE USE OF (UNKNOWN) PAIN MEDICATION. THEY FURTHER REPORTED THAT A MONTH AFTER CATHETER REMOVAL, A SCOPE TO BE USED TO DETERMINE IF ANY PIECES OF THE BALLOON WERE LEFT IN THE BLADDER. THE RESULTS OF THE SCOPING PROCEDURE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616098 FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL UNOMEDICAL SDN BHD MM53120805 407729R001

    Patients

    Seq Age Sex Outcome Treatment
    1