BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12055405 · Received June 23, 2021

    Report

    Report Number
    3004932373-2021-00300
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 2, 2021
    Report Date
    August 5, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. AN INITIATIVE UNDER AN EXISTING CAPA IS TO REPLACE LABS COATS WITH ELECTROSTATIC LAB COATS TO PREVENT HAIR FROM COMING INTO THE CONTROLLED MANUFACTURING ENVIRONMENT. FOLLOW UP E MDR PR3010380 H3 OTHER TEXT : PLEASE SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815 LOT NO.: 1040003. IT WAS REPORTED THAT HAIR WAS FOUND INSIDE OF THE PRODUCT PACKAGING. CUSTOMER STATED THAT WHEN THEY OPENED THE PACKAGE TO USE THE CHLORAPREP, THEY FOUND ONE PIECE OF HAIR ON THE SPONGE, AND THE ONE PIECE OF HAIR ON THE INSIDE OF THE PLASTIC PACKAGING. DOE: 6/2/2021. CUSTOMER STATED THEY WOULD LIKE A REPLACEMENT SENT TO THEM.

    Additional Manufacturer Narrative · 1

    (B)(4). PR (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.: 930815. LOT NO.: 1040003. IT WAS REPORTED THAT HAIR WAS FOUND INSIDE OF THE PRODUCT PACKAGING. CUSTOMER STATED THAT WHEN THEY OPENED THE PACKAGE TO USE THE CHLORAPREP, THEY FOUND ONE PIECE OF HAIR ON THE SPONGE, AND THE ONE PIECE OF HAIR ON THE INSIDE OF THE PLASTIC PACKAGING. DOE: 6/2/2021. CUSTOMER STATED THEY WOULD LIKE A REPLACEMENT SENT TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944166 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1040003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other