BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11074369 · Received December 27, 2020

    Report

    Report Number
    3004932373-2020-00162
    Event Type
    Malfunction
    Date Received
    December 27, 2020
    Date of Event
    November 25, 2020
    Report Date
    February 10, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLES SHOWS PRESENCE OF BLACK TINT WAS OBSERVED TO BE ADHERE ON APPLICATOR'S SURFACE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0135287 WERE REVIEWED AND NO DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT TO THE REPORTED ISSUE, HOWEVER IT WAS REPORTED AS PART OF MAINTENANCE LOGBOOK THAT TINT WAS LEAKING FROM THE PRINTER HEAD, THIS CAN CONTRIBUTE TO THE ¿FM¿ DEFECT OBSERVED WHICH WAS CONFIRMED TO BE TINT ADHERED TO THE APPLICATOR. PRINTER HEADS ARE BEING USED FOR PART NUMBERS THAT REQUIRE TO HAVE PRINTING INFORMATION ON THE APPLICATOR. WHEN UNPRINTED APPLICATORS ARE BEING PRODUCED ON THE MACHINE, THE PRINTER STATION IS BEING DISABLED. HOWEVER DURING THE MANUFACTURING OF THIS LOT, IT WAS OBSERVED LEAKAGE CAUSING TINT TO BE ADHERE TO UNPRINTED (NO TINT) APPLICATOR CODE. THE ROOT CAUSE IS RELATED TO PRINTER HEADS TINT LEAK WHEN THE PRINTER STATION IS DISABLED ON 3ML AUTO MACHINE #4. AS A CORRECTIVE ACTION, AN UPDATE TO THE MANUFACTURING PROCEDURE WAS DONE AND REMOVING THE PRINTER HEADS FROM THE PRINTER STATION WHEN NOT BEING USED HAS BEEN IMPLEMENTED. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    MATERIAL NO: 930415; BATCH NO: 0135287. IT WAS REPORTED THAT PRODUCT WAS REJECTED DUE TO FOREIGN MATTER EMBEDDED IN THE PACKAGING MATERIAL. REASON FOR REJECTION. FOREIGN MATTER, EMBEDDED IN PACKAGING MATERIAL. CUSTOMER RESPONSE: THE LOT # FOR THIS REJECT IS 0135287. WE DONT HAVE ANY PICTURES, BUT I JUST RECEIVED 200 MORE BACK FROM PRODUCTION AND IT APPEARS TO HAVE BLACK SPECS INSIDE THE PACKAGING. I¿LL NEED TO DO A REJECT ON THIS NEW BATCH THAT CAME IN, DO YOU WANT ALL OF THESE SENT BACK? DO YOU WANT TO HAVE 2 DIFFERENT SHIPMENTS? THANKS!

    Additional Manufacturer Narrative · 1

    (B)(4) 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.: 930415. BATCH NO.: UNKNOWN. IT WAS REPORTED THAT PRODUCT WAS REJECTED DUE TO FOREIGN MATTER EMBEDDED IN THE PACKAGING MATERIAL. REASON FOR REJECTION.. FOREIGN MATTER, EMBEDDED IN PACKAGING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538450 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0135287

    Patients

    Seq Age Sex Outcome Treatment
    1 Death