BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11817241 · Received May 13, 2021

    Report

    Report Number
    3004932373-2021-00241
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    August 5, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PHOTOGRAPH AND SAMPLE THE FAILURE MODE OF FOREIGN MATTER IS CONFIRMED. THE FAILURE MODE OF FOREIGN MATTER MOLD WAS NOT CONFIRMED DUE TO FTIR ANALYSIS AND VISUAL OBSERVATION. FTIR ANALYSIS WAS COMPLETED ON THE DARK MATERIAL OBSERVED ON THE PAD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWED THAT THIS MATERIAL IS MOST LIKELY POLYESTER URETHANE MIXED WITH SILICONE. A BATCH REVIEW WAS CONDUCTED AND FOUND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT.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. FOLLOW UP EMDR (B)(4).

    Description of Event or Problem · 0

    MATERIAL NO: 930815 AND BATCH NO: 1049217. IT WAS REPORTED THAT A FOREIGN SUBSTANCE APPEARING TO BE MOLD FOUND ON THE TIP OF THE SPONGE.   THIS MORNING DR. WENT TO PREP HIS PATIENT WITH A 26ML CHLORAPREP STICK, AND FOUND WHAT APPEARED TO BE MOLD ON THE TIP OF THE SPONGE. I HAVE THE STICK, ALONG WITH THE PACKAGING IN QUESTION, BUT I WANTED TO MAKE YOU ALL AWARE OF IT. HAS ANYONE ELSE SEEN THIS ON A CHLORAPREP STICK THEY HAVE OPENED? PLEASE ADVISE ON HOW TO PROCEED.

    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

    MATERIAL NO: 930815. BATCH NO: 1049217.   IT WAS REPORTED THAT A FOREIGN SUBSTANCE APPEARING TO BE MOLD FOUND ON THE TIP OF THE SPONGE.   VERBATIM: THIS MORNING DR. WENT TO PREP HIS PATIENT WITH A 26ML CHLORAPREP STICK, AND FOUND WHAT APPEARED TO BE MOLD ON THE TIP OF THE SPONGE. PLEASE SEE PICTURES BELOW. I HAVE THE STICK, ALONG WITH THE PACKAGING IN QUESTION, BUT I WANTED TO MAKE YOU ALL AWARE OF IT. HAS ANYONE ELSE SEEN THIS ON A CHLORAPREP STICK THEY HAVE OPENED? PLEASE ADVISE ON HOW TO PROCEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717736 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1049217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other