BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 11108869 · Received January 4, 2021

    Report

    Report Number
    3004932373-2020-00170
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    November 13, 2020
    Report Date
    February 18, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS ARE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DEFINED A ROOT CAUSE. RETAINED SAMPLES WERE ANALYZED AND NO ISSUE RELATED TO THE COMPLAINT WERE IDENTIFIED. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 260407I LOT NUMBER 0150729 WERE REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED ACUTE ALLERGIC REACTION.

    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 MHRAUK. PRIMEVIGILANCE DID REACH OUT TO OBTAIN 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

    MATERIAL NO.: (B)(4), BATCH NO.: 0150729. IT WAS REPORTED ACUTE ALLERGIC REACTION. REACTION(S) / EVENT(S) ASSESSED: ACUTE ALLERGIC REACTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8682 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0150729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other