BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11918087 · Received June 1, 2021

    Report

    Report Number
    3004932373-2021-00271
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 7, 2021
    Report Date
    September 1, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH IS NOT VERY CLEAR. THE FOAM TIP IS USUALLY WHITER THAN THE FOAM COLOR IN THE PHOTO WHICH MAY INDICATE THE COLOR WAS OFF AND DARKER THAN NORMAL. THE LIDDING IS WHITE WHERE IN THE PHOTO LOOKS DARKER OR BEIGE. BASED ON HISTORICAL EVENTS, MOST OF THE FM IS ORANGE DOTS/SPECS OR DARK PARTICLES. IT IS MORE LIKELY TO BE AN ORANGE DYE ON FOAM WHICH IS A VERY COMMON DEFECT DUE TO OUR PRODUCT AND DESIGN. THE ORANGE COLOR INSIDE THE PACKAGE DOES NOT INDICATE THE PRODUCT HAS BEEN ACTIVATED, LEAKING, OR IS DIRTY (FOREIGN MATTER). H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT EMBEDDED DEBRIS FOUND ON THE SPONGE. PER EMAIL: SC2021000602 136710 930815 PO: 951452263 LOT: 1106934 TOTAL QUANTITY: (B)(4) EACHES EMBEDDED DEBRIS FOUND ON SPONGE HELLO VENDOR, WE HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF MEDLINE ITEM NUMBER (136710) - CHLORAPREP APP 26ML ORANGE (REF. (B)(4)), WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF OUR KITS. IT WAS FOUND THAT THERE IS EMBEDDED DEBRIS FOUND ON SPONGE. WE WANT TO ENSURE THAT YOU ARE AWARE OF THIS ISSUE AND THAT WE DO REQUIRE A RESPONSE. PICTURES HAVE BEEN ATTACHED FOR YOUR REFERENCE OF THE NONCONFORMANCE IDENTIFIED.

    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

    IT WAS REPORTED BY THE DISTRIBUTOR THAT EMBEDDED DEBRIS FOUND ON THE SPONGE. PER EMAIL: SC2021000602 136710 930815, PO: 951452263. LOT: 1106934. TOTAL QUANTITY: 737 EACHES. EMBEDDED DEBRIS FOUND ON SPONGE. HELLO VENDOR, WE HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF MEDLINE ITEM NUMBER (136710) - CHLORAPREP APP 26ML ORANGE (REF. 930815), WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF OUR KITS. IT WAS FOUND THAT THERE IS EMBEDDED DEBRIS FOUND ON SPONGE. WE WANT TO ENSURE THAT YOU ARE AWARE OF THIS ISSUE AND THAT WE DO REQUIRE A RESPONSE. PICTURES HAVE BEEN ATTACHED FOR YOUR REFERENCE OF THE NONCONFORMANCE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811167 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1106934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other