BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER

    MDR report key: 3811193 · Received March 10, 2014

    Report

    Report Number
    3006260740-2014-00110
    Event Type
    Injury
    Date Received
    March 10, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 27, 2014
    Manufacturer
    C.R. BARD, INC. (BARD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CATHETER BROKE DURING THE ATTEMPTED REMOVAL. A SECOND DERMATOME WAS REQ'D TO REMOVE TUNNELED CATHETER AS IT HAD BECOME SIGNIFICANTLY SCARRED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143592 HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER LJS C.R. BARD, INC. (BARD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention