BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 13664678 · Received March 3, 2022

    Report

    Report Number
    3004932373-2022-00064
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 9, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE IS AVAILABLE. NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT 1035097. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ADVERSE REACTION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ADVERSE REACTION OCCURRED. VERBATIM: CHLORAPREP-GB-BD-22-000051-PLEASE FIND ATTACHED SOURCE DOCUMENT DOWNLOADED FROM MHRA TODAY WITH LRD: 20-FEB-2022 READY FOR TRIAGE. ANY UNAUTHORIZED DISSEMINATION OR COPYING OF THIS E-MAIL MESSAGE AND ANY USE OR DISCLOSURE OF INFORMATION CONTAINED IN IT IS STRICTLY PROHIBITED AND MAY BE ILLEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705813 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 1035097

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other