BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI- LITE ORANGE

    MDR report key: 12652755 · Received October 18, 2021

    Report

    Report Number
    3004932373-2021-00469
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 30, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE APPLICATOR FOAM TIP SCRUBBING SURFACE DOES NOT SHOW ANY DEFECT OR NON-CONFORMANCE; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. A ROOT CAUSE COULD NOT BE DETERMINED BASED ON PHOTOGRAPH RECEIVED FOR ANALYSIS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT: SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO: 272815. BATCH NO: 9120671. IT WAS REPORTED THAT BY THE HEALTH PROFESSIONAL AFTER USING THE CHLORAPREP APPLICATOR, SMALL LINT OR SCRAPS OF SKIN APPEARED ON THE PATIENT'S SKIN. VERBATIM: PER GOOGLE TRANSLATE - DURING A PRODUCT TEST AT THE STUTTGART CLINIC (OA MR. DR. (B)(6)), AFTER USING THE CHLORAPREP APPLICATOR, SMALL LINT OR SCRAPS OF SKIN (NO CLOSER INSPECTION POSSIBLE) APPEARED ON THE PATIENT'S SKIN. AT FIRST, DR. (B)(6) WAS OF THE OPINION THAT SMALL PARTICLES OF THE CHLORAPREP APPLICATOR (SPONGE) HAD COME OFF. ON CLOSER INSPECTION OF THE APPLICATOR (SEE PHOTO), HOWEVER, IT WAS PROBABLY ONLY THE DETACHMENT OF SMALL SKIN PARTICLES. THERE WAS NO REACTION ON THE PATIENT'S SKIN. THE APPLICATOR HAS BEEN TESTED IN THE CLINIC SINCE WEDNESDAY AND THE ISSUE DID NOT OTHERWISE ARISE. THE AFFECTED BATCH CAN BE FOUND IN THE ATTACHED PHOTO.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO: 272815, BATCH NO: 9120671. IT WAS REPORTED THAT BY THE HEALTH PROFESSIONAL AFTER USING THE CHLORAPREP APPLICATOR, SMALL LINT OR SCRAPS OF SKIN APPEARED ON THE PATIENT'S SKIN. VERBATIM: PER GOOGLE TRANSLATE - DURING A PRODUCT TEST AT THE STUTTGART CLINIC (OA MR. DR. /OMIT/), AFTER USING THE CHLORAPREP APPLICATOR, SMALL LINT OR SCRAPS OF SKIN (NO CLOSER INSPECTION POSSIBLE) APPEARED ON THE PATIENT'S SKIN. AT FIRST, DR./OMIT/ WAS OF THE OPINION THAT SMALL PARTICLES OF THE CHLORAPREP APPLICATOR (SPONGE) HAD COME OFF. ON CLOSER INSPECTION OF THE APPLICATOR (SEE PHOTO), HOWEVER, IT WAS PROBABLY ONLY THE DETACHMENT OF SMALL SKIN PARTICLES. THERE WAS NO REACTION ON THE PATIENT'S SKIN. THE APPLICATOR HAS BEEN TESTED IN THE CLINIC SINCE WEDNESDAY AND THE ISSUE DID NOT OTHERWISE ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545960 CHLORAPREP ONE STEP HI- LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 9120671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other