BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION TUBE

    MDR report key: 1901816 · Received November 17, 2010

    Report

    Report Number
    6000001-2010-04952
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION OF A HOLE ON THE TUBING WHICH RESULTED IN A LEAK. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE OF THIS CONDITION WAS NOT IDENTIFIED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET THAT HAD A LEAK. THE CONDITION WAS OBSERVED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1