BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR PAV SPLIT SET

    MDR report key: 1628911 · Received March 8, 2010

    Report

    Report Number
    9615050-2010-00033
    Event Type
    Malfunction
    Date Received
    March 8, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 11, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE TUBING SET WAS BEING USED FOR AN EPIDURAL DELIVERY OF AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME, THE TUBING DISCONNECTED AT AN UNSPECIFIED LOCATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. INFORMATION WAS REQUESTED FROM THE CUSTOMER REGARDING THE LOCATION OF THE DISCONNECTION, WHEN AND HOW THE DISCONNECTION WAS NOTED AND IF THE TUBING SET WAS REPLACED OR RECONNECTED; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR PAV SPLIT SET 80FRN FRN HOSPIRA COSTA RICA LTD NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR