BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3021743 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07298
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - THETFORD
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE UNIT ARRIVED ACTIVATED BY THE CUSTOMER. A VISUAL INSPECTION REVEALED A GREY PARTICLE PRESENT INSIDE THE SOLUTION OF THE DRUG VIAL. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS ATTRIBUTED TO THE METHOD IN WHICH THE USER ACTIVATED THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VIALMATE, CEFTRIAXONE 1G 50ML NACL 0.9%, HAD A GRAY PARTICLE FLOATING IN THE SOLUTION. THIS WAS NOTED DURING RECONSTITUTION OF AN UNKNOWN POWDERED ANTIBIOTIC. THE REPORTED CONDITION OCCURRED PRIOR TO PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, NOR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124278 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - THETFORD 12I25VM04

    Patients

    Seq Age Sex Outcome Treatment
    1