BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 11709745 · Received April 22, 2021

    Report

    Report Number
    3004932373-2021-00212
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 9, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PR (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE BD REPRESENTATIVE. PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CHLORAPREP WAS USED ON PATIENT'S EYE AND THE CORNEA WAS CLOUDY UNDER THE MICROSCOPE. PER MIQ REPORT: A BD EMPLOYEE (CLINICAL CONSULTANT - BIOSURGERY DIVISION/INFECTION PREVENTION) CALLED TO REPORT AN ADVERSE EVENT THAT SHE HEARD ABOUT FROM AN NHS EMPLOYEE (L.F., CONTACT DETAILS PROVIDED). A PATIENTS EYE WAS CLEANED WITH CHLORAPREP. IMMEDIATE IRRIGATION OF THE EYE UPON REALIZING THE CORNEA WAS CLOUDY UNDER THE MICROSCOPE. NO FURTHER INFORMATION WAS AVAILABLE, BUT THE BD EMPLOYEE DID FOLLOW-UP WITH THE REPORTER HERSELF AND SHE THINKS THIS MEANS THAT HE GRANTED CONSENT FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605509 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other