BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP HI-LITE ORANGE

    MDR report key: 10941464 · Received December 3, 2020

    Report

    Report Number
    3004932373-2020-00144
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 6, 2020
    Report Date
    January 13, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS AND TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE FAILURE MODE OF FOREIGN MATTER WAS CONFIRMED BY PHOTOGRAPHS AND SAMPLES RECEIVED FOR ANALYSIS. ONE PARTICLE WAS IDENTIFIED AS A PIECE OF CARDBOARD. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PROCESS OF MATERIAL RECEIVING UTILIZES CARDBOARD BOXES WHICH MAY SHED PARTICLES UNTO COMPONENTS/PLASTIC PACKAGE. THERE ARE SEGREGATED AREAS FOR UNPACKING OF COMPONENTS AND PACKING OF PRODUCT WHICH PREVENTS CARDBOARD FROM ENTERING THE CONTROLLED MANUFACTURING AREA. THE ROOT CAUSE IS THE PROCESS OF THE UTILIZATION OF CARDBOARD BOXES FOR COMPONENT RECEIVING WHICH IS PREVENTED BY HAVING A SEGREGATED AREA FOR UNPACKING (DE-TRASHING AREA). THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 260715C; BATCH NO.: 9115967 IT WAS REPORTED THAT THERE IS ORANGE STAINING AROUND THE BARREL AND SPONGE AND ALSO PIECES OF DEBRIS INSIDE THE PACKAGING. PER EMAIL: WE HAVE A TOTAL OF 40 260715C CHLORAPREP APPLICATORS THAT ARE EXHIBITING STAINING. I HAVE REMOVED THEM FROM STOCK AND HAVE THEM SEGREGATED IN MY OFFICE TO RETURN FOR INSPECTION ¿ PLEASE PROVIDE RETURN INSTRUCTIONS AND I WILL GET THESE SENT TO YOU. LOT# 9161963 14 EA; 9242668 11 EA; 9242658 15 EA. I HAD SENT THESE EDITS ALONG BUT YOU MUST NOT HAVE RECEIVED THEM. PLEASE MAKE THESE CHANGES BEFORE REACHING OUT TO THE CUSTOMER. ANY QUESTIONS, PLEASE REACH OUT TO ME. ANOTHER COMPLAINT HAS COME IN (NEW LOT#). PLEASE SEE BELOW AND PLEASE REACH OUT TO [OMITTED]. I RECEIVED THE REPLACEMENT 10.5ML CHLORAPREP ONE STEP APPLICATORS TODAY. UPON OPENING THE BOXES, I NOTICED THAT THE SAME STAINING IS EVIDENT ON MOST OF THE UNITS. OF PARTICULAR CONCERN, I FOUND TWO WITH DEBRIS INSIDE OF THE PACKAGING (BLUE ARROWS BELOW). ONE OF THE PIECES OF DEBRIS SEEMS TO BE WITHIN THE HEAT-SEALED AREA OF THE PACKAGING. IT IS POSSIBLE THAT THESE ARE FRAGMENTS OF SPONGE, BUT IN ANY CASE, THEY ARE VERY CONCERNING. THE LOT#'S OF THE REPLACEMENTS THAT YOU SENT ARE 9115967. I WILL KEEP THESE TWO BOXES SET ASIDE FOR NOW. PLEASE ADVISE NEXT STEPS.

    Additional Manufacturer Narrative · 1

    (B)(4); INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE PIECES OF DEBRIS INSIDE THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405354 CHLORAPREP ONE-STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 9115967

    Patients

    Seq Age Sex Outcome Treatment
    1 Other