BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12475157 · Received September 15, 2021

    Report

    Report Number
    3004932373-2021-00430
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 7, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 930299. BATCH NO.: UNKNOWN. IT WAS REPORTED CUSTOMER DISSATISFACTION WITH THE LEVEL OF PAD SATURATION BY CHLORAPREP SOLUTION. VERBATIM: DISSATISFACTION THE LEVEL OF PAD SATURATION BY CHLORAPREP SOLUTION FOR FREPP CHLORAPREP PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372512 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other