BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP HI-LITE ORANGE

    MDR report key: 12337681 · Received August 18, 2021

    Report

    Report Number
    3004932373-2021-00395
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    January 29, 2021
    Report Date
    September 27, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 930815 LOT NUMBER 0297753 WERE REVIEWED 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. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS .FAILURE MODE NOT CONFIRMED DUE TO NO SAMPLE OR PICTURES PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/ OR PREVENTIVE MEASURES DURING THE MANUFACTURING OF THE PRODUCT. FOLLOW UP EMDR (B)(4). H3 OTHER TEXT : SEE NARRATIVE SECTION BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815 BATCH NO.: 0297753. IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A HAIR. PER REPORT: HAIR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS A HAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235918 CHLORAPREP ONE-STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0297753

    Patients

    Seq Age Sex Outcome Treatment
    1