BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER, 16FR

    MDR report key: 3918894 · Received June 30, 2014

    Report

    Report Number
    1417592-2014-00065
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING CATHETER CARE, THE CATHETER BROKE DISTAL TO THE BALLOON INFLATION PORT. A PIECE WAS RETAINED IN THE BLADDER AND REMOVED VIA CYSTOSCOPY. NO SERIOUS INJURY RESULTED. THE SAMPLE WAS NOT RETAINED FOR EVALUATION. WE HAVE NO PHOTOS. IT IS NOT KNOWN HOW LONG THE CATHETER WAS IN PLACE PRIOR TO THE INCIDENT. WE HAVE NOT HAD ANY OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS DEVICE. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CATHETER BROKE AND THE RETAINED PIECE WAS REMOVED VIA CYSTOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378699 LATEX FOLEY CATHETER, 16FR NWR MEDLINE INDUSTRIES, INC. 14MB4205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R