BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 10469897 · Received August 30, 2020

    Report

    Report Number
    3004932373-2020-00023
    Event Type
    Malfunction
    Date Received
    August 30, 2020
    Date of Event
    August 5, 2020
    Report Date
    November 20, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS RECEIVED FOR ANALYSIS. THE FAILURE MODE OF FOREIGN MATTER (HAIR) WAS CONFIRMED BY THE SAMPLE SENT BY THE CUSTOMER. THE SAMPLE SHOWS A HAIR INSIDE THE ORIGINAL UNOPENED PACKAGE. THE LOT NUMBER # 0083021 AND EXPIRATION DATE 03/2023 ARE EMBOSSED ON THE BOTTOM WEB OF THE PACKAGE. THE HAIR ORIGINATES FROM AN OPERATOR. THE PROCESS HAS CERTAIN MANUAL PROCESSES THAT MAY RESULT IN HAIR ON THE PRODUCT. THE PROCEDURES / PROCESS INCLUDES PREVENTIVE MEASURES FOR HAIR IN PRODUCT. IT IS POSSIBLE FOR ASSOCIATES TO ACCIDENTALLY SHED HAIR ONTO PRODUCT AS THEY ARE LOADING COMPONENTS INTO THEIR CORRESPONDING CONTAINERS /PACKAGES, ALTHOUGH ASSOCIATES WEAR HAIR NETS, GLOVES, SAFETY GLASSES, AND HEAD COVERS; IF WORN IMPROPERLY IT COULD LEAD TO THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/ OR PREVENTIVE MEASURES DURING THE MANUFACTURING OF THE PRODUCT. PRODUCTION RECORD REVIEW FOR LOT 0083201 WAS COMPLETED AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT ON MARCH 27, 2020 PACKAGED ON K-12 AND ASSEMBLED ON AUTO 10.5ML #1. THIS IS THE ONLY COMPLAINT THAT HAS BEEN RECEIVED FOR THE REPORTED DEFECT AND LOT. CORRECTIVE ACTION WAS OPENED TO ADDRESS THE HAIR COMPLAINTS BY IMPLEMENTING GOWNING IMPROVEMENTS (HEAD COVER IMPROVEMENTS, LAB COAT GOWNING IMPROVEMENTS). NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. NO ADVERSE TREND OBSERVED. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A POTENTIAL HAIR WAS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POTENTIAL HAIR WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934241 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION, INC 0083021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other