BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 3093629 · Received May 1, 2013

    Report

    Report Number
    3006260740-2013-00192
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 19, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON ACCIDENTALLY CUT THE STYLET DURING PLACEMENT. THE DISTAL SEGMENT OF THE STYLET REMAINED INSIDE BODY OF THE PATIENT. THE STYLET WAS REMOVED ON THE SAME DAY. THE DOCTOR ADMITTED THAT HE WAS AT FAULT FOR THIS ACCIDENT; EVEN HE HAD SEVERAL EXPERIENCES FOR CATHETER PLACEMENT. THE PATIENT TEMPORARILY EXPERIENCED IRREGULAR HEARTBEATS DUE TO THIS ACCIDENT. THE PATIENT CONDITION IS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188980 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention