BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12178782 · Received July 15, 2021

    Report

    Report Number
    3004932373-2021-00328
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 21, 2021
    Report Date
    August 23, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXMEPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR PR (B)(4). THE FAILURE MODE OF FOREIGN MATTER (HAIR) WAS CONFIRMED BY THE PHOTOGRAPH PROVIDED BY THE CUSTOMER FOR ANALYSIS. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO.: NS930815, BATCH NO.:1063490. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT A HAIR AS FOUND INSIDE THE SEALED PACKAGE. PER EMAIL: PLEASE SEE THE ATTACHED PHOTOS. WE HAVE 2 CHLORAPREPS TODAY WITH HAIR INSIDE THE SEALED PACKAGE. THEY ARE FROM THE SAME BATCH, LOT # 1063490, EXP 02/2024. THEY OBVIOUSLY COULD NOT BE USED AS THEY WERE NO LONGER STERILE. I WILL BE PULLING THE REST OF THEM TOMORROW TO DOUBLE CHECK THEM. I HAVE ALSO COPIED OUR LOCAL BD REP ON THE EMAIL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: NS930815. BATCH NO.:1063490. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT A HAIR AS FOUND INSIDE THE SEALED PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074568 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 1063490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other