BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 4-PORT 15 FLTR 2CLV PE ORNG 216CM

    MDR report key: 3209750 · Received June 27, 2013

    Report

    Report Number
    9615050-2013-01758
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 29, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    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 EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) 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 CONTACT REPORTED A SEPARATION. ON AN UNSPECIFIED DATE, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE TUBING SET WAS PRIMED WITH AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME PRIOR TO PT USE, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED CLAVE SEPARATED FROM AN UNSPECIFIED THREE WAY CONNECTOR OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292333 PLUM 4-PORT 15 FLTR 2CLV PE ORNG 216CM UNK FRN HOSPIRA COSTA RICA LTD. NA 250525H

    Patients

    Seq Age Sex Outcome Treatment
    1