BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2193971 · Received August 5, 2011

    Report

    Report Number
    6000001-2011-16868
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CUSTOMER REPORTED CONDITION OF ''AN INTRAVIA EMPTY CONTAINER (250ML) IN WHICH A POTENTIAL REACTION WITH GENERIC AND UNDILUTED AKRON HYDROMORPHONE IS QUESTIONED DUE TO VISIBLE AIR BUBBLES DETECTED ON THE INSIDE OF THE PLASTIC CONTAINER'' WAS CONFIRMED DURING VISUAL INSPECTION OF REPORTED SAMPLE. ONE PHOTOGRAPH OF THE REPORTED CONTAINER WAS AVAILABLE FOR EVALUATION. DURING VISUAL INSPECTION, AIR BUBBLES WERE OBSERVED IN THE CONTAINER. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A PHOTO IS AVAILABLE FOR EVALUATION. THE EVALUATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) REGARDING THE INTRAVIA EMPTY CONTAINER (250ML) IN WHICH A POTENTIAL REACTION WITH GENERIC AND UNDILUTED AKRON HYDROMORPHONE, (B)(4), LOT NUMBER 041371, IS QUESTIONED DUE TO VISIBLE AIR BUBBLES DETECTED ON THE INSIDE OF THE PLASTIC CONTAINER ON (B)(6) 2011. THE CUSTOMER HAS BEEN USING THE INTRAVIA BAG FOR A LONG TIME, HOWEVER, THIS MAY BE THE FIRST TIME IT WAS USED FOR THE THIS MIXTURE. THE BAG ALREADY CONTAINED SODIUM CITRATE (0.2%) AND CITRIC ACID (0.2%), BUT THE BUBBLES DID NOT FORM UNTIL THE HYDROMORPHONE WAS ADDED. THE BAG WAS TAPPED FOR ABOUT 15 SECONDS TO REMOVE THE BUBBLES, BUT THEY COULD NOT BE REMOVED. PHARMACIST STATED THAT THE BAG WAS FILLED AND REFRIGERATED ON (B)(6) 2011. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, IV KPE BAXTER HEALTHCARE - AIBONITO UR11B21199

    Patients

    Seq Age Sex Outcome Treatment
    1 AKORN HYDROMORPHONE, SODIUM CITRATE, CITRIC ACID