BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAN 2000ML V/SAF 72

    MDR report key: 1404027 · Received June 12, 2009

    Report

    Report Number
    3005579246-2009-00002
    Event Type
    Other
    Date Received
    June 12, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 13, 2009
    Manufacturer
    HOSPIRA,INC.
    Product Code
    GCX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE REPORTED EVENT OF INADEQUATE SUCTION MAY BE DUE TO THE REUSE OF A SINGLE USE DEVICE. PACKAGE LABELING STATES: "THE CANISTER AND LID ARE DISPOSABLE AND INTENDED FOR SINGLE USE." 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 REUSE OF A SINGLE USE DEVICE; SUBSEQUENTLY, INADEQUATE SUCTION WAS NOTED. IT WAS REPORTED THAT DURING SET UP, A PREVIOUSLY USED LID WAS PLACED ON THE SUCTION CANISTER. THE CUSTOMER CONTACT REPORTED THAT THE LID SNAPPED ON EASIER THEN EXPECTED AND REPORTEDLY DID NOT FIT AS TIGHT AS EXPECTED; HOWEVER, THE SUCTION CANISTER WITH THE REUSED LID ATTACHED WAS PLACE INTO CLINICAL USE. AFTER A UNSPECIFIED LENGTH OF TIME IN USE, INADEQUATE SUCTION WAS NOTED. THE SUCTION CANISTER AND THE LID WERE REPLACED AND THE PROCEDURE WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAN 2000ML V/SAF 72 80GCX GCX HOSPIRA,INC. NA UNKSN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK