BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2571666 · Received May 11, 2012

    Report

    Report Number
    6000001-2012-10313
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    April 7, 2012
    Report Date
    April 19, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE ARRIVED OUT OF THE POUCH PRIMED. VISUAL INSPECTION SHOWED NO OBVIOUS ABNORMALITIES. THE SAMPLE WAS SPIKED INTO AN IN-HOUSE 1000ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER AND RE-PRIMED. THIS IDENTIFIED A LEAK APPROXIMATELY 12" PROXIMAL TO THE MIDDLE Y-SITE. CLOSER VISUAL INSPECTION UNDER A MICROSCOPE SHOWED THAT, THERE IS A CUT/GOUGE IN THE TUBING APPROX 3/8" IN LENGTH CAUSING THE LEAK. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES SENT NOTIFICATION OF A MEDWATCH TO BAXTER CORPORATE PRODUCT SURVEILLANCE REGARDING AN UNKNOWN ADMINISTRATION SET IN WHICH A LEAK WAS OBSERVED. ACCORDING TO THE REPORT, THE PATIENT'S MOTHER CALLED THE REGISTERED NURSE INTO THE ROOM BECAUSE SHE HAD OBSERVED WATER ON THE FLOOR UNDER THE IV POLE. THE REGISTERED NURSE OBSERVED A SMALL CRACK IN THE TUBING. THE MEDICATION BEING ADMINISTERED WAS NAFCILLIN. THE TUBING WAS CHANGED OUT, AND THERAPY CONTINUED AS NORMAL. THEREFORE, THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE AN UNKNOWN ADMINISTRATION SET IN WHICH A CRACK WAS OBSERVED ON AN UNKNOWN COMPONENT WHEN AN UNKNOWN DYE WAS ADDED. IT IS UNKNOWN WHEN THE ALLEGED DEFECT OCCURRED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO NAFCILLIN