BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12506366 · Received September 21, 2021

    Report

    Report Number
    3004932373-2021-00441
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    December 10, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE MODE IS CONFIRMED BASED ON THE SAMPLE PROVIDED BY YOUR FACILITY. THE SAMPLE HAS A HAIR INSIDE THE PACKAGE. PRODUCTION BATCH HISTORY RECORDS WAS REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE.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. 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.: A260815C; BATCH NO.: 1041911. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT A HAIR WAS FOUND INSIDE THE PACKAGING. PER COMPLAINT FORM: SINGLE HAIR NOTED INSIDE OF PACKAGING, PRIOR TO OPENING. STILL SEALED INSIDE. ANOTHER PACKAGE OBTAINED & USED WITH 0 ISSUES.

    Additional Manufacturer Narrative · 1

    (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.: A260815C. BATCH NO.: 1041911. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT A HAIR WAS FOUND INSIDE THE PACKAGING. PER COMPLAINT FORM: SINGLE HAIR NOTED INSIDE OF PACKAGING, PRIOR TO OPENING. STILL SEALED INSIDE. ANOTHER PACKAGE OBTAINED & USED WITH 0 ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403027 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1041911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other