BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11877629 · Received May 25, 2021

    Report

    Report Number
    3004932373-2021-00255
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    March 15, 2021
    Report Date
    August 31, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO POST MANUFACTURING HANDLING, WHICH CAN PROVIDE ENOUGH FORCE/IMPACT TO ACTIVATE AND BREAK THE GLASS AMPOULE. DUE TO THE NATURE OF GLASS, IT IS POSSIBLE TO HAVE AN ACTIVATED APPLICATOR AND/OR BROKEN AMPOULE IF THE APPLICATOR UNDERGOES EXCESSIVE HANDLING. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 312480 LOT NUMBER 0286480 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 FAILURE MODE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    WHEN USING THE MATERIAL, IT WAS EVIDENCED THAT IT WAS DRY. (WITHOUT 2% CHLORHEXIDINE GLUCONATE SOLUTION AND 70% ISOPROPYL ALCOHOL).

    Additional Manufacturer Narrative · 1

    PR 2841303 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: E2403. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A25.

    Description of Event or Problem · 1

    WHEN USING THE MATERIAL, IT WAS EVIDENCED THAT IT WAS DRY. (WITHOUT 2% CHLORHEXIDINE GLUCONATE SOLUTION AND 70% ISOPROPYL ALCOHOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777566 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0286480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other