BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2895003 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00151
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION WAS NOT CONFIRMED DURING THE SAMPLE EVALUATION. ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, THE OVER POUCH WAS OBSERVED TO BE OPENED BY ONE OF THE SEAMS; HOWEVER, NO HOLE WAS OBSERVED. NO OTHER TESTS WERE PERFORMED. THE SAMPLE WAS WORKING WITHIN SPECIFICATION. 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 BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MANAGER OF THE FACILITY REPORTED TO BAXTER (B)(4) A SOLUTION BAG IN WHICH THE OPERATOR FOUND A HOLE. THE REPORTED CONDITION OCCURRED BEFORE PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3282 IVT DISPOSABLE SET, I.V. FLUID TRANSFER KPE BAXTER HEALTHCARE - CALI SX09HF9

    Patients

    Seq Age Sex Outcome Treatment
    1