BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER EXT SET-JAPAN ONLYMICOBORE 2 ADAPTER Y-JUNCTION

    MDR report key: 1843506 · Received September 24, 2010

    Report

    Report Number
    6000001-2010-03507
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED BY THE SINGAPORE PLANT FOR EVALUATION ON SEPTEMBER 1, 2010. AN EVALUATION HAS NOT YET BEGUN. A FOLLOW UP REPORT WILL BE FILED ONCE THE EVALUATION IS COMPLETED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION FOR THE REPORTED CONDITION OF A SEPARATED INJECTION SITE OF THE SET. A VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE SEPARATED INJECTION SITE. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6), 2010 AN INCIDENT WHERE THE INJECTION SITE OF THE SET WAS SEPARATED WITH THE CATHETER EXTENSION SET. THIS INCIDENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER EXT SET-JAPAN ONLYMICOBORE 2 ADAPTER Y-JUNCTION SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1