BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY CONTAINER

    MDR report key: 3102459 · Received May 2, 2013

    Report

    Report Number
    9613251-2013-00119
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 3, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    KPE
    PMA / PMN Number
    K771228
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. ON AN UNSPECIFIED DATE AT THE COMPOUNDING FACILITY, THE EMPTY FLEXIBLE SOLUTION CONTAINER WAS FILLED WITH UNSPECIFIED VOLUME OF ROPIVACAINE 0.1% AND SUFENTANIL 0.5 MCG/ML IN 0.9% SODIUM CHLORIDE FOR A TOTAL VOLUME OF 250 ML. ON (B)(6) 2013, THE CUSTOMER CONTACT REPORTED THAT THE SOLUTION CONTAINER WAS DELIVERED TO AN END USER. AFTER THE SOLUTION CONTAINERS WERE DELIVERED TO THE END USER, IT WAS REPORTED THAT SOLUTION HAD LEAKED FROM THE RIGHT SEAM OF THE SOLUTION CONTAINER. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193389 EMPTY CONTAINER 80KPE KPE HOSPIRA LTD. NA 242004W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA