BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SUCTION 9/32"

    MDR report key: 1981424 · Received February 1, 2011

    Report

    Report Number
    1981424
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 27, 2010
    Report Date
    February 1, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING SUCTION PACKAGING TEARS AT THE GLUE LINE, MAKING STERILE DELIVERY IMPOSSIBLE.======================MANUFACTURER RESPONSE FOR TUBING SUCTION 9/32, TUBING SUCTION 9/32"======================FINAL REPORT STATED: IN A SIMILAR COMPLAINT WE RECEIVED SAMPLES THAT WERE EVALUATED ACCORDING TO OUR INSPECTION PROCEDURE AND WE COULD OBSERVE THE PACKAGE WITH A STRONG SEAL CAUSING IT TO TEAR. THE DEVICE HISTORY RECORDS FOR THE LOTS REPORTED WERE EVALUATED FOR ANY ISSUES RELATED WITH THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. OUR MANUFACTURING PROCESS CONDITIONS FOR THIS CODE GENERATE THAT THE PACKAGE IS SEALED WITH A GREAT SEAL FORCE. THIS CONDITION IS GENERATED FOR THE NORMAL PERFORMANCE OF THE MANUFACTURING PROCESS OF THE PRODUCT. NEW MATERIALS ARE BEING EVALUATED FOR THE NC TUBING CATALOGS IN ORDER TO ELIMINATE THE DIFFICULT AND TEARING PACKAGING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBING SUCTION 9/32" TUBING SUCTION 9/32 BYX CAREFUSION CORP * Y10K8111

    Patients

    Seq Age Sex Outcome Treatment
    1 *