BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12240139 · Received July 28, 2021

    Report

    Report Number
    3004932373-2021-00345
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    March 12, 2021
    Report Date
    July 23, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). SAMPLES WERE PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLES SHOWS BLACK SPECS ON SOME OF THE SAMPLES. THE SPECS WERE DIFFICULT TO FIND DUE TO THERE SMALL DIMENSIONAL SIZE. AS A RESULT, THE FAILURE MODE OF BLACK DOTS WAS VERIFIED ON THE SAMPLES ANALYZED. ONE POSSIBLE ROOT CAUSE OF THE BLACK SPECS IS THE PRINTER OF THE PACKAGING LIDDING. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCHES/LOTS 1054667, 1033703, 1055787 AND NO NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING OF THIS LOT. ON JUNE 30, 2021, THE MANUFACTURER UPDATED CURRENT WEEKLY PREVENTIVE MAINTENANCE TO INCLUDE A THOROUGH CLEANING OF ALL ROLLERS (ADDED IDLE ROLLERS ON THE PRINTER MACHINE, MARK ANDY EQUIPMENT). NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PACKAGING ISSUES. IT WAS CLARIFIED THAT BLACK DOTS APPEAR AND SMALL SPOTS OF CHLORAPREP LEAKING OUT PRIOR TO OPENING PER RESPONSE EMAIL: IT IS THE SAME ISSUE. THEY ARE HAVING BLACK DOTS APPEAR AND AND SMALL SPOTS OF CHLORAPREP LEAKING OUT PRIOR TO OPENING. I HAVE SPOKEN TO THE CUSTOMER MANY TIMES ABOUT THIS PER EMAIL: OF THE LAST 7 BX'S OF BD# 930815 WE'VE RECEIVED, WE HAVE HAD TO REMOVE 110 EA. FROM STOCK FOR THE SAME PACKAGING ISSUES WE WERE PREVIOUSLY HAVING. BREAKDOWN BY LOT NUMBER BELOW. IS BD GOING TO LOOK INTO THIS ISSUE? CAN YOU ISSUE RESTOCK FOR THE DAMAGED PRODUCT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134822 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1055787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other