BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECONSTITUTION DEVICE

    MDR report key: 1896985 · Received November 11, 2010

    Report

    Report Number
    6000001-2010-04810
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE COMPANION SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED NO NON-CONFORMANCES. A COMPRESSION TEST WAS PERFORMED ON THE NEEDLE AND THE RESULT WAS WITHIN ACCEPTANCE CRITERIA. THE REPORTED ISSUE COULDN'T BE CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A RECONSTITUTION DEVICE WHERE THE NEEDLE DISCONNECTED FROM THE CAP OF THE VIAL. THIS EVENT OCCURRED DURING RECONSTITUTION. THERE IS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. A COMPANION SAMPLE IS AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECONSTITUTION DEVICE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA 10F17V832M

    Patients

    Seq Age Sex Outcome Treatment
    1