BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3101822 · Received May 3, 2013

    Report

    Report Number
    9615050-2013-01044
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 1, 2009
    Report Date
    April 5, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THE LOT NUMBER OF THE DEVICES THAT WERE IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 230175H. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICES 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE PIERCING PIN PUNCTURING THE INTRALIPID SOLUTION CONTAINERS. THE TUBING SETS WERE TO BE USED TO DELIVER UNSPECIFIED CONCENTRATION S OF INTRALIPID SOLUTIONS. ON UNSPECIFIED DATES, THE CUSTOMER CONTACT REPORTED THAT THE CLINICIAN INSERTED THE PIERCING PINS OF THE TUBING SETS INTO THE ADMINISTRATION PORTS OF THE INTRALIPID CONTAINERS. AT THAT TIME, IT WAS NOTED THE PIERCING PINS PUNCTURED THE INTRALIPID CONTAINERS AT UNSPECIFIED LOCATIONS. THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUMES OF THE INTRALIPID SOLUTION LEAKED. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195274 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MANUFACTURED BY FRESENIUS (B)(4)| UNSPECIFIED INTRALIPID CONTAINERS: