BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L GROSHONG PICC WITH SAFETY IV CATH, BASIC KIT

    MDR report key: 3853678 · Received April 10, 2014

    Report

    Report Number
    3006260740-2014-00171
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    C.R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K871998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE; THE MANUFACTURING LOT NUMBER THAT WAS PROVIDED IS AN INCORRECT MANUFACTURING LOT NUMBER. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    AFTER THE FIRST SUCCESSFUL PUNCTURE, THE CATHETER HAD BEEN ADVANCED TO 30 CM THEN MET WITH RESISTANCE. PULLED OUT THE CATHETER AND CHECKED THEN FOUND THE CATHETER HAD BEEN IMPALED BY THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216863 4 FR S/L GROSHONG PICC WITH SAFETY IV CATH, BASIC KIT LJS C.R. BARD INC. (BASD) REVA2066

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention