BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 13502762 · Received February 9, 2022

    Report

    Report Number
    3004932373-2022-00044
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    February 3, 2022
    Report Date
    April 27, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    UDI-DI
    27613203026356
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: (B)(4). IMDRF ANNEX F CODE HEALTH EFFECT ¿ IMPACT CODE: (B)(4). IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: (B)(4). PR 4404957 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A PHOTOGRAPH WAS RECEIVED FOR ANALYSIS SHOWING HAIR INSIDE ORIGINAL UNOPENED 10.5ML PACKAGE CONFIRMING THE FAILURE MODE. THE HAIR ORIGINATES FROM AN OPERATOR. THE MANUFACTURING 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 THE 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. THIS PRODUCT WAS MANUFACTURED IN JANUARY 2021. NO FURTHER ACTION WILL BE TAKEN BASED ON A NEGATIVE TREND IS NOT OBSERVED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND FOR THIS DEFECT. H3 OTHER TEXT : SEE REMARK SECTION.

    Description of Event or Problem · 0

    MATERIAL NO: 270715 BATCH NO: UNKNOWN. [SAP LOOKUP - LOT 1111394 BELONG TO 932516]. IT WAS REPORTED THAT CUSTOMER FOUND HAIR IN CHLORAPREP PACKAGE. VERBATIM: IP- 270715-LOT 1111394 -EXTERNAL REF# (B)(4) -HAIR IN CHLORAPREP PACKAGE.

    Description of Event or Problem · 0

    MATERIAL NO: 270715, BATCH NO: UNKNOWN [SAP LOOKUP - LOT 1111394 BELONG TO 932516] IT WAS REPORTED THAT CUSTOMER FOUND HAIR IN CHLORAPREP PACKAGE. VERBATIM: IP- 270715-LOT 1111394 -EXTERNAL REF# (B)(4) -HAIR IN CHLORAPREP PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301371 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN 27613203026356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown