BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2230202 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21929
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE CONDITION WAS CONFIRMED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, 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) REGARDING A 500ML TRANSFER SET THAT CONTAINED PRIMENE 2% WITH DEXTROSE 10% AND ELECTROLYTES 250 ML. THE CUSTOMER REPORTED THAT THE DELIVERY DRIVER RETURNED A BOX THAT HAD BEEN SHIPPED TO THE HOSPITAL. THE DRIVER RETURNED THE BOX BECAUSE THE BOTTOM WAS WET. THE BOX CONTAINED 5 UNITS, ONE OF WHICH WAS LEAKING. THE REMAINING 4 UNITS WERE SHIPPED TO THE CUSTOMER. THE SAMPLE WAS RECEIVED SEALED IN ITS OVERPOUCH IN A SEALED SHIPPING BOX. THERE WAS LIQUID IN THE OVERPOUCH AND SHIPPING BOX. UPON REMOVAL OF THE SAMPLE FROM THE OVERPOUCH, THERE WAS MINIMAL LIQUID REMAINING IN THE SAMPLE. THE SITE OF THE LEAK COULD NOT BE DETERMINED, AS THE PRODUCT WAS VIRTUALLY EMPTY. REVIEW OF THE WORKSHEET HAS NO INDICATION OF ANY LEAK OBSERVED DURING PROCESSING AND PACKAGING. THE PROCESS STEP WAS DURING DELIVERY, PRIOR TO USE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMENE 2% WITH DEXTROSE 10% & ELECTROLYTES 250ML