BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM CLAVE Y

    MDR report key: 4137935 · Received September 29, 2014

    Report

    Report Number
    9615050-2014-05413
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 10, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK. THE PLUMSET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PATIENT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT AN UNSPECIFIED CHAMBER OF THE PLUMSET. NO SPECIFIC DETAILS WERE PROVIDED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604692 NDEHP PRIMARY PLUM CLAVE Y UNK FRN HOSPIRA COSTA RICA LTD. NA 371935H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA