BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11648572 · Received April 12, 2021

    Report

    Report Number
    3004932373-2021-00192
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 9, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE SHOWS A HAIR INSIDE THE PACKAGE ON THE FOAM TIP. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. 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. PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT: 0347762 AND NO NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING OF THIS LOT. AN INITIATIVE TO REPLACE LABS COATS WITH ELECTROSTATIC LAB COATS IS ON GOING PREVENTING HAIR COMING INTO THE CONTROLLED MANUFACTURING ENVIRONMENT. NO FURTHER ACTIONS ARE REQUIRED. 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 DARK HAIR FOUND WITHIN THE PRODUCT PACKAGING. PER EMAIL: PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. PLEASE CONTACT THE FACILITY DIRECTLY FOR DETAILS, SAMPLE COLLECTION AND RESOLUTION. WHEN THE INVESTIGATION HAS COMPLETED, PLEASE PROVIDE HEALTHTRUST WITH A COPY OF THE FINAL LETTER IN ORDER TO CLOSE OUT THE TICKET IN THE HEALTHTRUST DATABASE. I WILL FOLLOW UP WITH YOU FOR A STATUS UPDATE IN A COUPLE OF WEEKS. [OMITTED]: PRODUCT CATALOG NUMBER: 930715. PRODUCT DESCRIPTION: APPLICATOR 2% CHG 70% ISOPRPNL 1 STEP APL 10.5ML ORNG HI-LT. ORIGIN OF THE ISSUE: SURGERY. DETAIL: DARK HAIR FOUND WITHIN THE PRODUCT PACKAGING. NUMBER OF OCCURRENCES: 1.0. SAMPLE AVAILABLE: TRUE. LOT NUMBER: 0347762.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT: CLINICAL CODE: (B)(4). IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DARK HAIR FOUND WITHIN THE PRODUCT PACKAGING. PER EMAIL: PRODUCT CATALOG NUMBER: 930715. PRODUCT DESCRIPTION: APPLICATOR 2% CHG 70% ISOPRPNL 1 STEP APL 10.5ML ORNG HI-LT. ORIGIN OF THE ISSUE: SURGERY. DETAIL: DARK HAIR FOUND WITHIN THE PRODUCT PACKAGING. NUMBER OF OCCURRENCES: 1.0. SAMPLE AVAILABLE: TRUE. LOT NUMBER: 0347762.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547816 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0347762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other