BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    MDR report key: 4071862 · Received August 12, 2014

    Report

    Report Number
    9615050-2014-04789
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 23, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K982159. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. 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 DEVICE BREAKAGE. IT WAS REPORTED WHILE PREPARING FOR THE DELIVERY OF AN UNSPECIFIED MEDICATION, PRIOR TO PATIENT USE, THE TIP OF THE TUBING SET WAS BROKEN AT AN UNSPECIFIED LOCATION. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478970 PRIMARY PLUMSET PP YSITE 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA 271145H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA