BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 4427198 · Received January 13, 2015

    Report

    Report Number
    3006430057-2015-00003
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    November 17, 2014
    Report Date
    January 13, 2015
    Manufacturer
    INTEGRAL MEDICAL PRODUCTS CO. LTD.
    Product Code
    EZD
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REPORTED BLEEDING (B)(4) AND PAIN (B)(4) AFTER FORCEFULLY REMOVING A CATHETER THAT WAS DIFFICULT TO WITHDRAW (B)(4). THE CATHETER AND ITS PACKAGING FROM THE REPORTED EVENT WERE RETURNED TO THE SPECIFICATION DEVELOPER, BUT NOT EVALUATED BY INTEGRAL MEDICAL PRODUCTS CO, LTD, (B)(4). THE SPEC DEVELOPER CONFIRMED (B)(4) A V-SHAPED CUT NEAR THE EYELETS (B)(4), WHICH IS NOT INDICATIVE OF ANY MGF PROCESS EMPLOYED AT OUR ESTABLISHMENT BASED ON OUR PROCESS EVAL (B)(4). WE CONFIRMED EACH MFG STEP TO ENSURE THEY WERE MET AND FOLLOWED AND THAT THE DEVICE RECORDS REFLECT THESE PROCESSES (B)(4). ALTHOUGH NO CAUSE COULD BE FOUND IN OUR PROCESSES THAT COULD HAVE CREATED THAT CUT IN THE CATHETER TUBING, WE DO CONCLUDE THAT A FAILURE TO FOLLOW INSTRUCTIONS (B)(4) OCCURRED, BECAUSE ALL INSTRUCTIONS FOR INTERMITTENT SELF-CATHETERIZATION STATE "INSPECT CATHETER BEFORE USE. IF CATHETER OR PACKAGE IS DAMAGED DO NOT USE."

    Description of Event or Problem · 1

    PT REPORTED BLEEDING AND DISCOMFORT AFTER WITHDRAWING CATHETER. PT REPORTED THE CATHETER STOPPED AFTER BEING WITHDRAWN TWO INCHES AND HE HAD TO PULL HARD TO RELEASE THE CATHETER. PT EXPERIENCED DISCOMFORT AND OBSERVED SOME BLOOD IN URINE (HEMATURIA) AFTER CATHETERIZATION. PT HAS HAD SUCCESSFUL CATHETERIZATION SINCE EVENT. PT WAS PRESCRIBED ANTIBIOTIC AS A PRECAUTION TO POTENTIAL UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28076 CURE CATHETER UROLOGICAL CATHETER EZD INTEGRAL MEDICAL PRODUCTS CO. LTD. M14 140730-2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other HR LUBRICATING JELLY IN SINGLE-USE PACKETS