BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPIRA / ICU MEDICAL

    MDR report key: 2702055 · Received August 10, 2012

    Report

    Report Number
    MW5026503
    Event Type
    Injury
    Date Received
    August 10, 2012
    Manufacturer
    SET SOURCE
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV STARTED (B)(6). REPORTED IV LEAKING FOLLOWING DAY. ON (B)(6), PT READY FOR DISCHARGE AND COMPLAINED OF IV SITE REDNESS. IV DISCONTINUED. PRIOR TO DISCHARGE, GAUZE WAS REMOVED TO SITE, PURULENT DRAINAGE NOTED. REQUIRED ADD'L 6 DAY HOSPITAL STAY WITH TREATMENT FOR MITRAL VALVE VEGETATION, FOLLOWED BY IV ANTIBIOTICS AS OUTPATIENT. WE HAVE HAD 6 (TOTAL) PERIPHERAL IV-RELATED INFECTIONS SINCE IMPLEMENTATION OF NEW IV EXTENSION SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA / ICU MEDICAL 7" PRESSURE INFUSION EXT SET FPA SET SOURCE NA 13-038-JW

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization