BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 13192263 · Received January 7, 2022

    Report

    Report Number
    3004932373-2021-00552
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 14, 2021
    Report Date
    March 22, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    UDI-DI
    50885403427389
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE PACKAGING OF THE PRODUCT. GOWNING PROCEDURES REQUIRE OPERATORS TO WEAR HAIR NETS, GLOVES, SAFETY GLASSES AND HEAD COVERS. IF PROTECTIVE EQUIPMENT IS WORN IMPROPERLY IT IS POSSIBLE FOR ASSOCIATES TO ACCIDENTALLY SHED HAIR ONTO THE PRODUCT AS THEY ARE LOADING COMPONENTS INTO THEIR CORRESPONDING CONTAINERS/PACKAGES. AN INITIATIVE UNDER OUR CURRENT CAPA IS TO REPLACE LAB COATS TO PREVENT HAIR FROM COMING INTO THE CONTROLLED MANUFACTURING ENVIRONMENT. ANTI-ELECTROSTATIC COATS STARTED TO BE IMPLEMENTED ON JUNE 2021. FOLLOW UP EMDR (B)(4).

    Description of Event or Problem · 0

    MATERIAL NO: 260815C, BATCH NO: UNKNOWN (PROVIDED 1091519 03/2024). IT WAS REPORTED FM - HAIR. VERBATIM: THERE IS A HAIR INSIDE OF THE STERILE PACKAGING OF THE 26ML CHLORAPREP APPLICATOR NONE - THE ITEM WAS INSPECTED PRIOR TO USE ON THE PATIENT & THE CONTAMINANT WAS SEEN. THE CUSTOMER WOULD LIKE TO RECEIVE REPLACEMENT PRODUCT.

    Description of Event or Problem · 0

    MATERIAL NO: 260815C. BATCH NO: UNKNOWN (PROVIDED 1091519 0ON 3/2024). IT WAS REPORTED FM - HAIR. THERE IS A HAIR INSIDE OF THE STERILE PACKAGING OF THE 26ML CHLORAPREP APPLICATOR NONE - THE ITEM WAS INSPECTED PRIOR TO USE ON THE PATIENT & THE CONTAMINANT WAS SEEN. THE CUSTOMER WOULD LIKE TO RECEIVE REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794508 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1091519 50885403427389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other