BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2231426 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22054
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF Y-TYPE CATHETER EXTENSION SET/LEUR LOCK ADAPTER IN WHICH SET CAME APART AT THE Y-JUNCTION WAS CONFIRMED BY LOOKING AT THE LOGS FOR SIMILAR REPORTS RECEIVED FOR THIS SET IN LAST TWO YEARS. THE ASSIGNABLE ROOT CAUSE FOR THE REPORTED CONDITION WAS FOUND TO BE IMPROPER ASSEMBLY METHOD PERFORMED BY THE MANUFACTURING-LINE ASSOCIATES. THE MANUFACTURING LINE ASSOCIATES WERE NOTIFIED AND THE MANUFACTURING PROCEDURE WAS UPDATED AS A CORRECTIVE ACTION OF THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER US THAT THE Y-TYPE CATHETER EXTENSION SET/LUER LOCK ADAPTERS WAS ATTACHED TO AN INFANT'S FEMORAL ARTERIAL LINE ON (B)(6) 2011 DURING PATIENT USE. THIS EXTENSION SET CAME COMPLETELY APART AT THAT JUNCTION, CAUSING THE CENTRAL LINE TO BE OPEN AND ULTIMATELY RESULTED IN THE OCCLUSION OF THE INFANT'S FEMORAL LINE. THE PHYSICIAN CHANGED OUT THE EXTENSION SET FOR ANOTHER EXTENSION SET OF THE SAME PRODUCT CODE AND NO FURTHER ISSUES WERE NOTED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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