BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L.C. 5000/ CE NITROGLYCERIN PUM

    MDR report key: 3258491 · Received July 23, 2013

    Report

    Report Number
    9615050-2013-02155
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 24, 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
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K982159. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPRIA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A HOLE; SUBSEQUENTLY, A LEAK WAS NOTICED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF SALINE. THE CUSTOMER CONTACT REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, AN PERFORATION WAS NOTED AT AN UNSPECIFIED LOCATION OF THE TUBING SET. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT AN UNSPECIFIED LOCATION OF THE TUBING SET. THE TUBING SET WAS NOT REPLACED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342344 L.C. 5000/ CE NITROGLYCERIN PUM UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA