BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12336384 · Received August 18, 2021

    Report

    Report Number
    3004932373-2021-00380
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    January 15, 2021
    Report Date
    September 21, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    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

    NO SAMPLE OR PHOTOGRAPH WAS RECEIVED FOR ANALYSIS; THEREFORE, THE FAILURE MODE COULD NOT BE CONFIRMED, NOR THE ROOT CAUSE BE DETERMINED.COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT 0126294. FOLLOW UP EMDR FOR PR 3300505.

    Description of Event or Problem · 0

    MATERIAL NO.: 930700 AND BATCH NO.: 0126294. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE DEVICE WAS MISSING THE LABEL. PER REPORT: NO LABEL.

    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 BY THE DISTRIBUTOR THAT THE DEVICE WAS MISSING THE LABEL. PER REPORT: NO LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234200 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 0126294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other