BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 13670239 · Received March 4, 2022

    Report

    Report Number
    3004932373-2022-00065
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 14, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE SHOWS SMALL ORANGE DOT/SPECS ON THE LIDDING VERIFYING THE REPORTED ISSUE. THE ORANGE DYE IS NOT OF FOREIGN MATTER BUT IS A AN INACTIVE INGREDIENT INHERIT IN THE PRODUCT BY DESIGN. THE ORANGE DYE POWDER MAY BE DISPERSED TO THE OUTSIDE OF THE APPLICATOR ON RARE OCCASIONS DURING THE ASSEMBLY, AND PACKAGING. ALSO, DURING THE STERILIZATION WHICH USES VAPOR (WATER), WHEN IN CONTACT WITH THE ORANGE DYE BRINGS OUT EXAGGERATES THE ORANGE COLOR INTENSITY. THE ORANGE DYE IS USED ON THE APPLICATOR AS PART OF THE DESIGN TO COLOR THE SOLUTION UPON ACTIVATION BY BREAKING THE AMPOULE AND SOLUTION FLOWING THRU THE HI-LITE ORANGE PLEDGET (WITH THE ORANGE DRY POWDER DYE) AS A VISUAL PREPPING CONFIRMATION ON THE PATIENT¿S SKIN. THE ORANGE COLOR INSIDE THE PACKAGE DOES NOT INDICATE THE PRODUCT HAS BEEN ACTIVATED, LEAKING, OR IS DIRTY (FOREIGN MATTER). THE APPLICATOR IS STERILE IF PACKAGE IS INTACT. THE MOST PROBABLE ROOT CAUSE FOR ORANGE DYE AROUND THE ORANGE TINTED PLEDGET IS THE EQUIPMENT, PROCESS AND/OR MATERIAL VARIABILITY INHERENT TO THE PROCESS AND DESIGN. NO PRODUCTION RECORD REVIEW WAS COMPLETED AS THE BATCH/LOT INFORMATION WAS UNAVAILABLE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    **#7- SRG-IP DEFECTIVE PRODUCT- CLORA-PREP ( LEAKING ); CREDIT ONLY. (B)(4). 1-EA MATERIAL # 930815HELLO TEAM, GOOD DAY MAY WE SEEK ASSISTANCE FOR CREDIT OR RETURN OF A DEFECTIVE ITEM. " DEFECTIVE PRODUCT- CLORA-PREP ( LEAKING ); (B)(4) ITEM - 930815 1EA YOUR ASSISTANCE IS HIGHLY APPRECIATED THANK YOU, (B)(6). (B)(4). CUSTOMER SUPPORT SERVICES PHONE: 800.964.5227 / FAX: 866.303.6710 (B)(4). DID YOU KNOW YOU CAN USE CARDINAL HEALTH MARKET<HTTPS://URLDEFENSE.COM/V3/__HTTP://MARKET.CARDINALHEALTH.COM__;!!(B)(4) TO SEARCH FOR PRODUCTS, VERIFY PRICE/AVAILABILITY, PLACE/TRACK ORDERS, RESEARCH ORDERS, PRINT INVOICES AND MORE? VISIT US AT CARDINAL HEALTH MARKET<HTTPS://URLDEFENSE.COM/V3/__HTTP://MARKET.CARDINALHEALTH.COM__;!!(B)(4). ISSUES OR CONCERNS WITH CARDINAL HEALTH MARKET? CALL EIT SUPPORT @ 1-800-326-6457, OPTION 3, OPTION 1. ***DO NOT DELETE*** (B)(4). ORIGINAL TEXT FROM: "(B)(4)@CARDINALHEALTH.COM> TO: (B)(4)-CUSTOMERSUPPORT <(B)(4)[email protected]> CC: SENT: 02/03/2022 14:48:20 SUBJECT: ACTION REQUIRED: CUSTOMER (B)(4) DEFECTIVE ITEMS CARDINAL HEALTH PRODUCTS & SERVICES

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRODUCT IS LEAKING. VERBATIM: **#7- SRG-IP DEFECTIVE PRODUCT- CLORA-PREP ( LEAKING ); CREDIT ONLY (B)(4). HELLO TEAM, GOOD DAY MAY WE SEEK ASSISTANCE FOR CREDIT OR RETURN OF A DEFECTIVE ITEM. " DEFECTIVE PRODUCT- CLORA-PREP ( LEAKING ); (B)(4). ITEM - 930815 1EA. YOUR ASSISTANCE IS HIGHLY APPRECIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177955 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other