BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3150679 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14524
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - THETFORD
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE NOTED THAT THE BACKING PAPER WAS DETACHED FROM THE CLEAR BLISTER PACKAGING. IT WAS FURTHER NOTED THAT THERE WAS NOT A STRONG BOND BETWEEN THE BLISTER PACKAGING AND THE BACKING PAPER. THE CAUSE WAS DETERMINED TO BE FROM THE MANUFACTURING PROCESS. A CAPA HAS BEEN OPENED IN ORDER TO ADDRESS THIS ISSUE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VIAL-MATE?S BLISTER PACKAGING WAS LOOSE ON THE BACKSIDE OF THE PAPER. THIS MALFUNCTION WAS IDENTIFIED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250832 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - THETFORD 13A31VM01

    Patients

    Seq Age Sex Outcome Treatment
    1