BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100X60

    MDR report key: 3529457 · Received October 22, 2013

    Report

    Report Number
    9615050-2013-04219
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    September 23, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. TESTING AND INVESTIGATION IS COMPLETE. THE DEVICE WAS NOT RECEIVED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED RUBBER LID CANNOT COVER UP WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K101677. 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 THE RUBBER LID CANNOT COVER UP. ON AN UNSPECIFIED DATE, AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE RUBBER LID CANNOT COVER UP. NO SPECIFIC DETAILS WERE PROVIDED. NO INFORMATION WAS PROVIDED IF THE EVENT OCCURRED DURING PATIENT INVOLVEMENT OR PRIOR TO PATIENT INVOLVEMENT; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542041 SOLUSET 100X60 UNK FPA HOSPIRA COSTA RICA LTD. NA 152415G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK