BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 1.5LITER PE/CE WITH (50/CASE)

    MDR report key: 2199446 · Received August 1, 2011

    Report

    Report Number
    9613251-2011-00165
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 4, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    GCX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 80GCX AND A 510K OF K831939. 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 LOSS OF SUCTION. THE DEVICE WAS BEING USED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED AS SOON AS THE SUCTION STARTED, "WASTE FLUID WAS NOT SUCKED INTO THE RECEPTAL LINER." THE SUCTION LINER WAS REPLACED AND THE PROCEDURE WAS RESUMED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL 1.5LITER PE/CE WITH (50/CASE) UNK GCX HOSPIRA LTD. NA UNKKZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK