BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN SECONDARY SET

    MDR report key: 2083358 · Received April 13, 2011

    Report

    Report Number
    9616066-2011-00118
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CODAN US CORP
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 04/13/2011. (B)(4). THE CUSTOMER'S REPORT OF A BREAK RESULTING IN A LEAK WAS CONFIRMED. THE MALE LUER TIP OF THE CODAN SECONDARY SET WAS OBSERVED TO BE BROKEN AND REMAINED INSIDE THE SMARTSITE VALVE. THE MALE LUER TIP INSIDE THE SMARTSITE KEPT THE SMARTSITE VALVE OPEN, RESULTING IN A LEAK. THE SMARTSITE WAS DETERMINED TO BE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE MALE LUER TIP BREAKING OFF INSIDE THE SMARTSITE WAS NOT IDENTIFIED. THE MANUFACTURER OF THE SECONDARY SET, CODAN, HAS BEEN NOTIFIED OF OUR FINDINGS.

    Description of Event or Problem · 1

    PER CUSTOMER'S MEDWATCH REPORT: "PATIENT RECEIVING FLAGYL IV. UPON REMOVING PIGGYBACK TUBING AT Y-SITE AT COMPLETION OF INFUSION, THE CONNECTION PORT SEEMED TO BE BROKEN AS SALINE WAS SPEWING OUT OF IT. NEW TUBING OBTAINED. THE PREVIOUS TUBING HAD BEEN IN USE FOR 30 HOURS (THIS TUBING IS NORMALLY USED FOR 72 HRS). NO HARM TO PATIENT." MANUFACTURER'S REPORT DATE: APRIL 13, 2011. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODAN SECONDARY SET FPA CODAN US CORP 4900-0000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR ALARIS PUMP MODULE: SERIAL # UNKNOWN| ALARIS PUMP MODULE ADMINISTRATION SET: 2420-0007| ALARIS PC UNIT: SERIAL # UNKNOWN| LOT NUMBER UNKNOWN