BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 11097142 · Received December 30, 2020

    Report

    Report Number
    3004932373-2020-00165
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    December 18, 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 AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE AND DEFINE A PROBABLE ROOT CAUSE AT THIS TIME. RETAINED SAMPLES WERE ANALYZED AND NO ISSUES 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. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD AN ALLERGY WHILE USING CHLORAPREP.

    Additional Manufacturer Narrative · 1

    (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.: 260407I, BATCH NO.: 0150729. IT WAS REPORTED THE PATIENT HAD AN ALLERGY WHILE USING CHLORAPREP. REACTION / EVENT AS REPORTED BY THE PRIMARY SOURCE IN NATIVE LANGUAGE: ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559043 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