BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP PRIMARY PLUM CLAVE Y

    MDR report key: 1702858 · Received May 24, 2010

    Report

    Report Number
    9615050-2010-00100
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    March 21, 2010
    Report Date
    May 4, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED TO THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K865060. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED HYDRATION SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE NURSE NOTED, THE TUBING HAD SEPARATED FROM THE SECURE LOCK MALE ADAPTER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP PRIMARY PLUM CLAVE Y UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK