BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD PRIMARY IV SET WITH NON-DEHP TUBING

    MDR report key: 1113443 · Received April 4, 2008

    Report

    Report Number
    9613251-2008-00078
    Event Type
    Malfunction
    Date Received
    April 4, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    k971293
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH REC'D THAT STATED: TUBE SEPARATION. NURSE REPORTED THAT WHEN SPIKING IV BAG WITH PRIMARY IV SET, THE SEGMENT OF TUBING FROM THE SPIKE TO THE UPPER Y-SITE (CLAVE) SEPARATED FROM THE Y-SITE. NURSE OBTAINED ANOTHER PRIMARY SET AND SET UP IV. NO ADVERSE PT EVENT; NO DELAY IN STARTING PROCEDURE". UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED A TUBING SEPARATION. PRIOR TO PT USE WHILE THE NURSE WAS SPIKING AN UNSPECIFIED IV SOLUTION BAG, THE TUBING SEPARATED FROM THE LEG OF THE UPPER Y-SITE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD PRIMARY IV SET WITH NON-DEHP TUBING 80-FPA FPA HOSPIRA LTD. NA 600184W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN