BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION PRM 16FR CATH SECURE

    MDR report key: 3131294 · Received May 21, 2013

    Report

    Report Number
    9612030-2013-00016
    Event Type
    Other
    Date Received
    May 21, 2013
    Report Date
    April 26, 2013
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A PRECISION 16FR CATHETER. THE CUSTOMER STATED THE CATHETER BALLOON RUPTURED AFTER SEVEN DAYS AFTER INSERTION. THE FACILITY PERFORMED A CYSTOSCOPY TO VERIFY AND REMOVE RETAINED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225148 PRECISION PRM 16FR CATH SECURE CATHETER KOD COVIDIEN PP16XSD 231750364

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other