BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF CONV PP OL 2 C

    MDR report key: 1618765 · Received February 25, 2010

    Report

    Report Number
    9615050-2010-00023
    Event Type
    Malfunction
    Date Received
    February 25, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 1, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WIL NOT BE RETURNED FOR INVESTIGATION. 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 THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE OPENED POSITION; SUBSEQUENTLY, A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECOND TUBING SET WAS CONNECTED TO THE CLAVE PORT OF THE PRIMARY TUBING SET FOR DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CHEMOTHERAPEUTIC AGENT DELIVERY WAS COMPLETED AND THE MALE ADAPTER WAS REMOVED FROM THE CLAVE PORT. AT THAT TIME, IT WAS NOTED THAT THE SILICONE SLEEVE OF THE CLAVE PORT REMAINED IN THE OPEN POSITION AND AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE PRIMARY TUBING SET WAS REPLACED AND THE NORMAL SALINE DELIVERY WAS RESUMED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY IN THERAPY CRITICAL FOR 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 LS LF CONV PP OL 2 C 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY PIGGYBACK TUBING SET| LIST # 19701, LOT # UNK