BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER K

    MDR report key: 2052109 · Received March 1, 2011

    Report

    Report Number
    3006260740-2011-00057
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 9, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS THOUGHT THAT THIS SLEEVE HAS BEEN INSERTED INTO THE PATIENT DURING THE PROCEDURE AND LEFT INSIDE. THEY WERE UNAWARE OF THIS EXTRA COMPONENT, THEY FEEL IS NOT EASY TO SEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER K LJS C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention