BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3955043 · Received July 24, 2014

    Report

    Report Number
    1416980-2014-24048
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCORRECT MANUFACTURING DATE WAS INADVERTENTLY SUBMITTED IN THE INITIAL MEDWATCH. THE MANUFACTURING DATE RANGE IS 11/05/2014 TO 11/07/2014. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 ADAPTER LEAKED. THIS OCCURRED WHEN A CLINICIAN TRIED RECONSTITUTING A 500 MG VIAL OF AZITHROMYCIN WITH NORMAL SALINE BY SHAKING THE 20 MM VIAL. THE REPORTER STATED THAT THE DRUG LEAKED ON HER SKIN. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434000 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND GR13J07042

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR 500 MG VIAL OF AZITHROMYCIN| NORMAL SALINE