BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA EMPTY STERILE

    MDR report key: 2844388 · Received November 5, 2012

    Report

    Report Number
    1021343-2012-00108
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 8, 2012
    Manufacturer
    HOSPIRA INC.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION 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, IT WAS REPORTED THAT THE VIAL WAS FILLED WITH AN UNSPECIFIED PAIN MEDICATION AND WAS LOADED INTO AN UNSPECIFIED PATIENT CONTROLLED ANALGESIA (PCA) PUMP. NO SPECIFIC PUMP PROGRAMMING WAS PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT SOLUTION LEAKED FROM AN UNSPECIFIED LOCATION OF THE INJECTOR IN THE VIAL. THE VIAL WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA EMPTY STERILE 80MEA MEA HOSPIRA INC. NA 16248R1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK