BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP FREPP

    MDR report key: 12337180 · Received August 18, 2021

    Report

    Report Number
    3004932373-2021-00388
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    March 30, 2021
    Report Date
    September 15, 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

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. A REVIEW OF THE CLEAN AND USE LOGBOOK FOR THE MACHINE SHOWS THAT THE MACHINE WAS CLEANED PRIOR TO LOT START-UP. A DEFINITE ROOT CAUSE CAN'T BE IDENTIFIED WITHOUT AN ACTUAL SAMPLE OR A PICTURE OF THE DEFECT. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE PACKAGING OF THE PRODUCT. GOWNING PROCEDURES REQUIRE OPERATORS TO WEAR HAIR NETS, GLOVES, SAFETY GLASSES AND HEAD COVERS. IF PROTECTIVE EQUIPMENT IS WORN IMPROPERLY IT IS POSSIBLE FOR ASSOCIATES TO ACCIDENTALLY SHED HAIR ONTO THE PRODUCT AS THEY ARE LOADING COMPONENTS INTO THEIR CORRESPONDING CONTAINERS/PACKAGES. AN INITIATIVE WAS STARTED TO REPLACE LAB COATS TO PREVENT HAIR FROM COMING INTO THE CONTROLLED MANUFACTURING ENVIRONMENT. ANTI-ELECTROSTATIC COATS STARTED TO BE IMPLEMENTED ON JUNE 2021. WHILE THE LOT IN QUESTION PN 930299 LN 0253622 WAS MANUFACTURED ON JULY 2020, WHICH IS BEFORE THE CONTINUED INITIATIVE OF REPLACEMENT OF ANTI-STATIC LAB COATS. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS OF THE AFFECTED DEVICE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE DEVICE HAD HAIR.

    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 THE DEVICE HAD HAIR. PER REPORT: PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236882 CHLORAPREP ONE STEP FREPP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0253622

    Patients

    Seq Age Sex Outcome Treatment
    1 Other