BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER, 16F

    MDR report key: 3232261 · Received July 9, 2013

    Report

    Report Number
    1417592-2013-00058
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CATHETER WAS REMOVED DURING A SURGICAL PROCEDURE IN ORDER TO INSERT A CYSTOSCOPE. DURING THE CYSTOSCOPY, A FOREIGN OBJECT WAS VISUALIZED IN THE BLADDER AND WAS DETERMINED TO BE THE TIP OF THE FOLEY CATHETER. THE SAMPLE WAS NOT RETURNED FOR EVAL BUT WAS DESCRIBED AS MEASURING ABOUT 3-4 INCHES IN LENGTH. THE RISK MANAGER DID NOT KNOW WHAT PROCEDURE WAS BEING PERFORMED OR IF ANY SURGICAL INSTRUMENTS COULD HAVE POSSIBLY DAMAGED THE INTEGRITY OF THE CATHETER. WE HAVE NOT HAD A SIMILAR INCIDENT REPORTED TO US FOR THIS CATHETER. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    DURING A CYSTOSCOPY, THE TIP OF THE FOLEY CATHETER WAS FOUND IN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313737 FOLEY CATHETER, 16F NWR MEDLINE INDUSTRIES, INC. 12LB7632

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R