BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11771324 · Received May 4, 2021

    Report

    Report Number
    3004932373-2021-00229
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 21, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE AND PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF BOTH THE SAMPLE AND PHOTOS VERIFIED THE PRESENCE OF A HAIR. 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 HAS BEEN IMPLEMENTED TO REPLACE LABS COATS WITH ELECTROSTATIC LAB COATS TO PREVENT HAIR FROM COMING INTO THE CONTROLLED MANUFACTURING ENVIRONMENT. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0238164 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT RELATED TO FM HAIR. NO FURTHER ACTIONS WILL BE TAKEN 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

    IT WAS REPORTED A HAIR OR HAIR-LIKE FIBER WAS FOUND INSIDE THE CHLORAPREP PACKAGING. PER EMAIL: TODAY WE FOUND A STERILE PRODUCT THAT WHEN OPENED HAD A HAIR OR HAIR LOOKING FIBER ON IT. I AM INCLUDING PHOTOS OF THE HAIR AND PACKAGING. [USER] SAID THIS WAS NOT FROM INSIDE A PACK.

    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

    IT WAS REPORTED A HAIR OR HAIR-LIKE FIBER WAS FOUND INSIDE THE CHLORAPREP PACKAGING. PER EMAIL: TODAY WE FOUND A STERILE PRODUCT THAT WHEN OPENED HAD A HAIR OR HAIR LOOKING FIBER ON IT. I AM INCLUDING PHOTOS OF THE HAIR AND PACKAGING. [USER] SAID THIS WAS NOT FROM INSIDE A PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668973 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0238164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other