BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11542874 · Received March 22, 2021

    Report

    Report Number
    3004932373-2021-00142
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 22, 2021
    Report Date
    August 10, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTOS SHOWS A HAIR INSIDE THE PACKAGING WHICH VERIFIED THE REPORTED ISSUE. 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, GLOBES, 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0062670 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. AN AWARENESS TRAINING WAS PERFORMED TO INFORM THE ASSOCIATED RELATED IN THE MANUFACTURING AND PACKAGING OF 3 ML PRODUCT ABOUT THIS CUSTOMER COMPLAINT. NO FURTHER ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED A HAIR WAS LOCATED INSIDE THE POUCH. PER SUPPLIER NCR: 2 PIECES OF MATERIAL U-45703-005 BATCH 13P21A0534 WERE FOUND WITH A HAIR INSIDE THE POUCH.

    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 WAS LOCATED INSIDE THE POUCH. PER SUPPLIER NCR: 2 PIECES OF MATERIAL U-45703-005 BATCH 13P21A0534 WERE FOUND WITH A HAIR INSIDE THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438813 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0062670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other