BEUDAMED
    FDA Adverse Event Death Summary report: N

    HICKMAN 7FR DL CVC PEEL-APART INTRO KIT W/SURECUFF

    MDR report key: 3879364 · Received June 3, 2014

    Report

    Report Number
    3006260740-2014-00281
    Event Type
    Death
    Date Received
    June 3, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE IS BEING RETAINED BY THE REPORTING FACILITY. THE REPORTING FACILITY HAS DECIDED NOT TO RELEASE ANY FURTHER INFORMATION IN RELATION TO THIS EVENT. THEREFORE, DATE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT: DURING THE INSERTION OF THE DILATOR, THE MEDIASTINUM WAS INJURED. REPORTEDLY, THE PATIENT EXPIRED. DETAILS ARE UNDER INVESTIGATION. MEDICON'S OBSERVATION: NO SAMPLE RECEIVED. PER MEDICON, THE HOSPITAL IS NOT RELEASING ANY ADDITIONAL DETAILS. THEREFORE, THE DATE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324335 HICKMAN 7FR DL CVC PEEL-APART INTRO KIT W/SURECUFF LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death