BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-CATH

    MDR report key: 7040531 · Received November 17, 2017

    Report

    Report Number
    7040531
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    April 26, 2017
    Report Date
    May 4, 2017
    Manufacturer
    COLOPLAST CORP.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLACED AN 8FR. TAPERED TIP COUDE CATHETER IN A PATIENT. AS CONTRAST WAS INFUSED INTO THE PATIENTS BLADDER, I NOTICED THAT THE CATHETER WAS LEAKING AT THE HUB. STOPPED CONTRAST AND TAPED THE HUB AND CONTINUED INFUSION. MANUFACTURER RESPONSE FOR SELF CATHETER TAPERED TIP COUDE 8 FRENCH, SELF CATH (PER SITE REPORTER): LOCAL REP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820278 SELF-CATH CATHETER, RETENTION TYPE, BALLOON EZL COLOPLAST CORP. 504650 4584735

    Patients

    Seq Age Sex Outcome Treatment
    1