BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11770740 · Received May 4, 2021

    Report

    Report Number
    3004932373-2021-00227
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 8, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DEFINE A PROBABLE ROOT CAUSE AT THIS TIME. IF ADDITIONAL INFORMATION, SAMPLES, OR PHOTOS BECOME AVAILABLE, THE RECORD WILL BE RE-OPENED AND INVESTIGATED ACCORDINGLY. NO ROOT CAUSE COULD BE DEFINED AT THIS TIME AS NO SAMPLES, PHOTOS OR THE PRODUCT BATCH/LOT IS UNAVAILABLE. PRODUCTION RECORD REVIEW COULD NOT BE COMPLETED AS NO BATCH/LOT INFORMATION IS AVAILABLE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPONGE WAS DRY. PER EMAIL: MEDICAL ACTION INDUSTRIES RECENTLY RECEIVED A COMPLAINT FOR THE BELOW ISSUE INVOLVING YOUR CHLORAPREP# 930480NSB THAT WAS PLACED IN OUR KITS. THE QUANTITY AFFECTED IS APPROXIMATELY 2 EA. THERE IS NO LOT NUMBER OR SAMPLE/PHOTO FOR THIS COMPLAINT. THIS NOTIFICATION IS FOR AWARENESS ONLY. WE DO NOT REQUIRE A RESPONSE FROM BD. COMPLAINT ISSUE: CHLORAPREP SPONGES IN IV START KITS ARE DRY. THE LOT NUMBER IS UNKNOWN AND ISSUE HAS BEEN INTERMITTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664865 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other