BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1850556 · Received October 1, 2010

    Report

    Report Number
    6000001-2010-03707
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE REPORTED CONDITION WAS CONFIRMED SINCE AN ELLIPTICAL CUT WAS DETECTED ON THE TUBING. A BATCH REVIEW WAS CONDUCTED AND THERE WAS AN EXCEPTION FOUND IN THIS BATCH; THE WRONG TUBING WAS USED; HOWEVER, ACTIONS WERE TAKEN TO RESOLVE THIS EXCEPTION AND THE AFFECTED SETS INVOLVED WERE ALL DISCARDED. SINCE THE AFFECTED SETS WERE DISCARDED, THIS EXCEPTION WAS NOT RELATED TO THIS COMPLAINT. THE CAUSE OF THE REPORT IS UNKNOWN. NO FURTHER ACTION IS NEEDED AT THIS TIME. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A LARGE (1 CM LONG), ELLIPTICAL HOLE IN A SET CAUSING THE FLUID PATHWAY TO BE UNSTERILE. THE REPORTED CONDITION WAS NOTICED AFTER PRIMING AND LEFT PATIENT WITHOUT INTENDED INTRAVENOUS PARENTERAL NUTRITION FLUID FOR 24 HOURS. THE PATIENT WAS GIVEN ANOTHER BAG. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR10612057

    Patients

    Seq Age Sex Outcome Treatment
    1