BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF VENILOOP NON-DEHP

    MDR report key: 2180737 · Received May 5, 2011

    Report

    Report Number
    9613251-2011-00076
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. PRODUCT LABELING FOR THIS DEVICE STATES, "USE ASEPTIC TECHNIQUE. REMOVE CAPS WHEN REQUIRED AND SECURE CONNECTIONS." THIS REPORT REPRESENTS ALL THE INFO 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 DISCONNECTIONS. THE MALE ADAPTERS OF UNSPECIFIED TUBING SETS WERE CONNECTED TO THE REMOVAL CLAVE PORTS OF THE EXTENSION SETS. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE REMOVAL CLAVE PORTS DISCONNECTED FROM THE EXTENSION SETS; SUBSEQUENTLY BLEED BACK WAS NOTED. THE EXTENSION SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPY CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF VENILOOP NON-DEHP 80FPK FPK HOSPIRA, LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1