BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA EMPTY STERILE

    MDR report key: 3802803 · Received February 21, 2014

    Report

    Report Number
    1021343-2014-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 19, 2014
    Report Date
    January 22, 2014
    Manufacturer
    HOSPIRA INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER'S REPORTED COMPLAINT OF LEAK COULD BE DETERMINED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS. IT WAS REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTION LEAKED DURING MANUAL FILLING OF THE VIALS AT THE USER FACILITY. THE CUSTOMER CONTACT REPORTED THE VIALS WERE BEING FILLED WITH UNSPECIFIED CONCENTRATION OF DILAUDID WHEN SOLUTION LEAKED AROUND THE BLUE STOPPER IN THE VIALS. IT WAS REPORTED THAT THE BLUE STOPPER APPEARED TO BE CROOKED IN THE VIALS. THE VIALS WERE REPLACED AND THE FILLING RESUMED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109007 PCA EMPTY STERILE 80MEA MEA HOSPIRA INC. NA 80490R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA