BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3240327 · Received July 18, 2013

    Report

    Report Number
    9615050-2013-02104
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THAT THE PIERCING PIN OF TUBING SETS PUNCTURING STEM CELL CONTAINERS. ON AN UNSPECIFIED DATE, THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF DONOR STEM CELLS TO A PATIENT WHO WAS INTENTIONALLY IMMUNOSUPPRESSED IN PREPARATION FOR A DONOR STEM CELL TRANSPLANT. THE CUSTOMER CONTACT REPORTED THAT AS THE NURSE WAS INSERTING THE PIERCING PIN OF THE TUBING SET INTO THE ADMINISTRATION PORT OF THE STEM CELL CONTAINER, THE PIERCING PIN PUNCTURED THE STEM CELL CONTAINER AT AN UNSPECIFIED LOCATION. IT WAS REPORTED THAT AN UNSPECIFIED SYRINGE WAS CONNECTED TO THE ADMINISTRATION PORT OF THE STEM CELL CONTAINER AND THE STEM CELLS WERE DELIVERED TO THE PATIENT. THE PHYSICIAN WAS NOTIFIED AND ORDERED AN UNSPECIFIED CONCENTRATION OF VANCOMYCIN TO BE GIVEN TO THE PATIENT TO PREVENT INFECTION. THE CUSTOMER CONTACT REPORTED THE PATIENT WAS SUCCESSFULLY GRAFTED AND THAT THERE WAS NO EVIDENCE OF POST TRANSPLANT INFECTION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334175 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNSPECIFIED STEM CELL CONTAINER: MFR UNK