BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL UNKNOWN

    MDR report key: 2854475 · Received November 29, 2012

    Report

    Report Number
    8040412-2012-00191
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 18, 2012
    Report Date
    November 7, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: FUNNEL DETACHED FROM CATHETER. AN ATTEMPT TO RE-CATHETERIZE PT WAS UNSUCCESSFUL. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL UNKNOWN UNK RUSCH URINARY CATH SIZE 8 BSR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1