BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD POSI FLUSH PRE FILLED SALINE SYRINGE

    MDR report key: 7133807 · Received December 19, 2017

    Report

    Report Number
    MW5074116
    Event Type
    Death
    Date Received
    December 19, 2017
    Date of Event
    December 14, 2017
    Report Date
    December 18, 2017
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT NEW TO DIALYSIS LESS THAN TWO WEEKS. JUST FINISHED TREATMENT, PREFILLED SALINE BD POSI FLUSH GIVEN THROUGH LINES TO FLUSH NECK CATH, PT WENT INTO SYNCOPE AND THEN CARDIAC ARREST, 911 CALLED, REGAINED PULSE BEFORE TRANSPORT BUT DIED SAME DAY. DOSE OR AMOUNT: 20 ML MILLILITRE(S). ROUTE: INTRAVENOUS. DIAGNOSIS OR REASON FOR USE: DIALYSIS FLUSH LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911435 BD POSI FLUSH PRE FILLED SALINE SYRINGE POSI FLUSH FOZ BD

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death