BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11085080 · Received December 28, 2020

    Report

    Report Number
    3004932373-2020-00164
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 2, 2020
    Report Date
    February 12, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE HAS BEEN RECEIVED FOR EVALUATION. VISUAL EXAMINATION FOR THE SAMPLE SHOWS A LIGHT BROWN HAIR INSIDE AN OPENED PACKAGE. AS A RESULT, BD WAS ABLE TO VERIFY THE FAILURE. 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. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815 , BATCH NO.: 0171976. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PACKAGING. HAIR IN PACKAGE ITEM 930815, LOT 0171976.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 930815; BATCH NO.: 0171976. IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PACKAGING. HAIR IN PACKAGE ITEM 930815. LOT 0171976.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548605 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0171976

    Patients

    Seq Age Sex Outcome Treatment
    1 Other