BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2173713 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13637
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLES ARE REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS PRE-AMENDMENT; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER.

    Description of Event or Problem · 1

    BAXTER RECEIVED NOTIFICATION (B)(4) OF AN UNKNOWN NUMBER OF EVACUATED CONTAINERS - 1000ML IN WHICH A VACUUM LOSS WAS OBSERVED. ACCORDING TO THE REPORT, DURING A PARACENTESIS PROCEDURE, THERE WAS NO VACUUM FROM THE BOTTLE WHEN THE DRAINAGE TUBE WAS INSERTED. THIS ALSO HAPPENED WITH SEVERAL OTHER BOTTLES FROM THIS SAME LOT. WHEN A NEW LOT OF BOTTLES WAS USED NO PROBLEMS WERE OBSERVED. THE CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINERS, IV KPE BAXTER HEALTHCARE - CLEVELAND G09359

    Patients

    Seq Age Sex Outcome Treatment
    1