BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PRE-FILLED NORMAL SALINE SYRINGES

    MDR report key: 7518009 · Received May 16, 2018

    Report

    Report Number
    MW5077222
    Event Type
    Death
    Date Received
    May 16, 2018
    Date of Event
    December 28, 2017
    Report Date
    May 15, 2018
    Manufacturer
    BD
    Product Code
    NGT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THE SYRINGES HER SISTER WAS USING WERE CONTAMINATED WHICH LED TO HER UNTIMELY DEATH. PATIENT DEVELOPED C-DIFF AND WAS IN AND OUT OF THE HOSPITAL DUE TO REOCCURRING INFECTIONS. THE PATIENT WAS USING THE DEVICE FROM (B)(6) 2007 - (B)(6) 2018. THE REPORTER RECEIVED A RECALL LETTER ON MAY 9TH CONFIRMING THE DEVICE HAD BEEN CONTAMINATED AND RECALLED OFF THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359863 BD PRE-FILLED NORMAL SALINE SYRINGES SALINE, VASCULAR ACCESS FLUSH NGT BD 715911C

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H