BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2851237 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06135
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF A VIALMATE THAT WAS OBSERVED TO BE LOOSE WAS CONFIRMED DURING SAMPLE EVALUATION. THE ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SAMPLES WERE UNLOCKED. VIALMATE WAS DISMANTLED FOR FURTHER INSPECTION. DURING EXAMINATION OF THE VIALMATE, IT WAS NOTICED THAT THE VIALMATE LOCKING SYSTEM WAS LOOSE. SINCE THE RETURNED VIALMATE WAS ALREADY UNLOCKED, THE UNLOCKING FORCE COULD NOT BE TESTED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS DUE TO MEASUREMENT ISSUE AT THE MANUFACTURING FACILITY. ADDITIONAL INFORMATION: BATCH FILE REVIEW WAS NOT POSSIBLE, SINCE BATCH NUMBER PROVIDED WAS NOT RECOGNIZED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BAXTER (B)(4) OF A VIALMATE THAT WAS OBSERVED TO BE LOOSE. THE REPORTED CONDITION OCCURRED BEFORE PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1