BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12569064 · Received October 4, 2021

    Report

    Report Number
    3004932373-2021-00454
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 7, 2021
    Report Date
    November 2, 2021
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTOS SHOWS FOREIGN MATERIAL ON THE SPONGE OF THE APPLICATORS PICTURED. THIS VERIFIED THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE PACKAGING OF THE PRODUCT SUCH CLEANING ACTIVITIES. THE PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 0170675 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. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    THEY REPORT THAT DURING THE MANUFACTURING PROCESS THEY FIND 6 PIECES THAT PRESENT FOREIGN PARTICLES ON THE SPONGES. ___ FOREIGN PARTICLES: PR# (B)(4). SPOTS/DOTS: PR# (B)(4). *** ADDITIONAL INFORMATION RECEIVED ON 10/07/2021: OF THE 6 PIECES: 5 PIECES WITH FOREIGN PARTICLES AND 1 PIECE WITH SPOTS. ****

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THEY REPORT THAT DURING THE MANUFACTURING PROCESS THEY FIND 6 PIECES THAT PRESENT FOREIGN PARTICLES ON THE SPONGES. FOREIGN PARTICLES: (B)(4). SPOTS/DOTS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470545 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF 0170675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other