BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 11154821 · Received January 12, 2021

    Report

    Report Number
    3004932373-2020-00179
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    December 16, 2020
    Report Date
    March 18, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS AVAILABLE FOR EVALUATION. DURING THE ANALYSIS, IT WAS OBSERVED THAT AN AMPOULE WAS MISSING AND THE APPLICATOR WAS FULLY ASSEMBLED. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AN EVALUATION WAS DONE ON THE ASSEMBLY MACHINE 3ML AUTO #4 SINCE PRODUCT IS 100% INSPECTED FOR AMPOULE PRESENCE. DURING THIS EVALUATION, AN OPPORTUNITY WAS OBSERVED ON THE VERIFICATION FREQUENCY OF THE AMPOULE PRESENCE SENSOR FUNCTIONALITY. THE VERIFICATION IS BEING DONE AS PART OF MACHINE PREVENTIVE MAINTENANCE ACTIVITIES ONCE A WEEK, HOWEVER IT WAS DETECTED THAT SENSOR POSITION CAN BE MISALIGNED DURING MANUFACTURING ACTIVITIES POTENTIALLY WHEN A LOT CHANGE OCCURS BEFORE PREVENTIVE MAINTENANCE ACTIVITIES ARE BEING DONE. MISALIGNMENT IN POSITION OF THE AMPOULE PRESENCE SENSOR CAN GENERATE FAILURES ON THE 100% INSPECTION PROCESS. THE MOST PROBABLE ROOT CAUSE WAS ATTRIBUTED TO AN EQUIPMENT FAILURE THAT PLACES AMPOULES INSIDE THE APPLICATORS AND INADEQUATE MAINTENANCE ON EQUIPMENT AMPOULE DETECTION SENSOR. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 931490 LOT NUMBER 0050733 WERE REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS. AN AWARENESS SESSION WAS CONDUCTED WITH PRODUCTION PERSONNEL. NO FURTHER ACTION ARE REQUIRED AT THIS TIME. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS NO LIQUID INSIDE THE APPLICATORS. NO LIQUID IN THE 1.5ML APPLICATOR, PRODUCT CODE: 931490.

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: 931490 BATCH NO.: 0050733 IT WAS REPORTED THAT THERE IS NO LIQUID INSIDE THE APPLICATORS. NO LIQUID IN THE 1.5ML APPLICATOR, PRODUCT CODE: 931490 PER EMAIL: PLEASE FIND ATTACHED. THIS IS THE LATEST QUALITY DEFECT WE RECEIVED FROM OUR CUSTOMER. PLEASE ADVISE IF SAMPLES NEED TO BE SENT FOR INVESTIGATION SO WE CAN ORGANISE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53150 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other