BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE FUSION, THORACENTESIS CATHETER

    MDR report key: 3963579 · Received July 24, 2014

    Report

    Report Number
    MW5037464
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CARE FUSION
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CAREFUSION THORACENTESIS CATHETER TIP BROKE OFF DURING THORACENTESIS AND WAS NOT RECOVERED IMMEDIATELY. THE TIP WAS RECOVERED DURING SURGICAL INTERVENTION ON (B)(6) 2014. THE PHYSICIAN REPORTS THAT THE CATHETER IS DIFFICULT TO USE, COMPARED TO OTHER BRANDS. STATES CATHETER IS TOO FRIABLE AND IS EASILY SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434857 CARE FUSION, THORACENTESIS CATHETER CATHETER LRO CARE FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R