BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    MDR report key: 3249744 · Received July 19, 2013

    Report

    Report Number
    9615050-2013-02117
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 21, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WERE DISCARDED. 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 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 LEAKS. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES. AFTER UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTIONS LEAKED FROM UNSPECIFIED LOCATIONS OF THE TUBING SETS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339183 PRIMARY PLUMSET 2 CLAVES 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK