BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUBER NEEDLE SET 22GA 25MM

    MDR report key: 1871819 · Received October 16, 2010

    Report

    Report Number
    6000001-2010-04092
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    LDKS OVERSAN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE REPORTED MALFUNCTION IS ALLEGED AGAINST A PRODUCT THAT BAXTER DOES NOT HAVE REPORTING RESPONSIBILITY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. A PHOTOGRAPH OF THE SAMPLE WAS AVAILABLE FOR REVIEW; THE SEPARATION WAS CONFIRMED THROUGH VISUAL INSPECTION. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(6), ON (B)(6) 2010 AN INCIDENT WHERE THE TUBING CAME OUT FROM THE CONNECTION TO THE HUBER SPIKE WITH THIS HUBER NEEDLE 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 HUBER NEEDLE SET 22GA 25MM SET, ADMINISTRATION, INTRAVASCULAR FPA LDKS OVERSAN 0725

    Patients

    Seq Age Sex Outcome Treatment
    1