BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIV

    MDR report key: 2223223 · Received August 9, 2011

    Report

    Report Number
    2223223
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 9, 2011
    Manufacturer
    HOSPIRA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN NURSE HUNG IV BAG OF SALINE, SALINE LEAKED OUT OF HOLES ALONG THE RIGHT VERTICAL SEAM OF THE BAG. THE BAG WAS NOT PUNCTURED DURING USE.======================MANUFACTURER RESPONSE FOR IV BAG, VISIV (PER SITE REPORTER)======================REQUESTING BAGS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIV IV CONTAINER KPE HOSPIRA 1000ML 0.9% SODIUM CHORIDE 05-111-06

    Patients

    Seq Age Sex Outcome Treatment
    1 *