BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2122036 · Received May 24, 2011

    Report

    Report Number
    9613251-2011-00104
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 25, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 A DISCONNECTION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF LACTATED RINGER'S SOLUTION VIA GRAVITY DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO AN INSYTE AUTOGUARD 20 GAUGE IV CATHETER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, A LEAK OF SOLUTION WAS NOTED. IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SET DISCONNECTED FROM THE IV CATHETER. IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS RECONNECTED TO THE CATHETER AND THE CONNECTION WAS TIGHTENED AND SECURED WITH TAPE. THE THERAPY 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 LSLF EXT SET W CLV 80FPK FPK HOSPIRA LTD. NA UNKNS

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #1054734 MFG BY BECTON DICKENSON| INSYTE AUTOGUARD IV CATHETER: LIST #381434