BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    MDR report key: 3364749 · Received September 12, 2013

    Report

    Report Number
    9615050-2013-02985
    Event Type
    Injury
    Date Received
    September 12, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 16, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 232075H. 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 INFORMATION KNOWN BY THE REPORTER REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE "EX TEMPORANE INJECTION SITE." THE CUSTOMER CONTACT INDICATED THAT THE PT EXPERIENCED A REPORTED IMPORTANT BLOOD LOSS. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING CLARIFICATION OF EX TEMPERANCE INJECTION SITE, IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED, IF THERE WAS ANY DELAY OF THERAPY CRITICAL TO THE PT, IF ANY MEDICAL INTERVENTIONAL'S WERE REQUIRED, AND THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460484 PRIMARY PLUMSET PP YSITE 272CM NDEHP UNK FPA HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other