BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12259827 · Received August 2, 2021

    Report

    Report Number
    3004932373-2021-00347
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    July 7, 2021
    Report Date
    September 1, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE OR PHOTOGRAPH WAS RECEIVED FOR ANALYSIS; THEREFORE, THE FAILURE MODE COULD NOT BE CONFIRMED, NOR THE ROOT CAUSE BE DETERMINED NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. FOLLOW UP EMDR (B)(4).

    Description of Event or Problem · 0

    MATERIAL NO.: 930815. BATCH NO.: 1079456. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THE APPLICATOR CAUSED SKIN TEARS ON THE PATIENT'S ABDOMEN. PER EMAIL: ON (B)(6) 2021 DURING PREP FOR A PLANNED PROCEDURE, A 26 ML CHLORAPREP APPLICATOR, LOT#1079456 EXP 03/2024 WAS USED ON THE PATIENTS ABDOMEN AND RESULTED IN SKIN TEARS FROM THE APPLICATOR. THIS IS NOT PART OF THE RECENT RECALL BUT AS THE MANUFACTURER WE FELT YOU NEEDED TO BE MADE AWARE OF THIS INCIDENT AS IT WAS SIMILAR TO THE PREVIOUS RECALL. PLEASE ADVISE ON NEXT STEPS TO ENSURE OUR PATIENTS SAFETY.

    Additional Manufacturer Narrative · 1

    PR (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

    MATERIAL NO.: 930815; BATCH NO.: 1079456. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THE APPLICATOR CAUSED SKIN TEARS ON THE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154802 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1079456

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other