BEUDAMED
    FDA Adverse Event Summary report: N

    PRI SYMBIQ PIGGY CHECK 2 CLAVE 0.2 FIL

    MDR report key: 1942458 · Received November 9, 2010

    Report

    Report Number
    9615050-2010-00228
    Date Received
    November 9, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED RATE VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, AN UNSPECIFIED TUBING SET WITH A CLOSED MALE CONNECTOR ATTACHED TO THE MALE LUER WAS CONNECTED TO THE LOWER CLAVE Y-SITE PORT OF THE PRIMARY TUBING TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED A LEAK OF FLUID FROM THE CONNECTION OF THE CLAVE Y-SITE PORT AND CLOSED MALE CONNECTOR. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRI SYMBIQ PIGGY CHECK 2 CLAVE 0.2 FIL 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# UNK, (B)(4)| SPIROS CLOSED MALE CONNECTOR, LIST # 20120,