BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS EXTSET YS NON-CONVER PIN POUCH PACK

    MDR report key: 3243205 · Received July 18, 2013

    Report

    Report Number
    9615050-2013-02095
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK; SUBSEQUENTLY, AIR WAS NOTED IN THE TUBING SET. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT THE REPORTED MEMBRANE OF THE TUBING SET. AFTER AN UNSPECIFIED LENGTH OF TIME, AN UNSPECIFIED VOLUME OF AIR WAS NOTED AT AN UNSPECIFIED LOCATION OF THE TUBING OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336505 GS EXTSET YS NON-CONVER PIN POUCH PACK 80FPA FPA HOSPIRA COSTA RICA LTD. NA 221385H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK