BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 8FR

    MDR report key: 2142104 · Received May 26, 2011

    Report

    Report Number
    8040412-2011-00077
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    February 23, 2011
    Report Date
    May 6, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGED: THE STYLET BROKE AFTER INSERTION, IT WAS IMPOSSIBLE TO REMOVE ALL THE STYLET. THE CATHETER (WITH REMAINING PART OF THE STYLET) WAS REMOVED AND A NEW ONE WAS SUCCESSFULLY INSERTED. NO PART REMAINED INSIDE THE PT. THE PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 8FR FOLEY CATHETER KOD TELEFLEX MEDICAL NA 10DE14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK