BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12288315 · Received August 6, 2021

    Report

    Report Number
    3004932373-2021-00361
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 14, 2021
    Report Date
    September 22, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS AND SAMPLES WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION WAS COMPLETED AND VERIFIED THE REPORTED ISSUES OF FOREIGN MATTER. BLACK SPECS AND WHAT LOOKS TO BE A PIECE OF WOOD FROM THE SWAB HANDLE WAS IDENTIFIED. THE ROOT CAUSE OF THE DEFECT LIES ON THE CLEANLINESS OF THE MACHINES DURING THE MANUFACTURING OF THIS LOT. IN THE PAST SEVERAL MONTHS A CLEANING INITIATIVE PART OF MAINTENANCE PROJECT HAS BEEN IN THE WORKS TO IMPROVE THE EQUIPMENT CLEANLINESS. ALSO, THERE ARE WEEKLY, AND MONTHLY PREVENTIVE ACTIVITIES THAT ENCOMPASS THE CLEANING OF THE EQUIPMENT. ON JUNE 30, 2021, THE WEEKLY PREVENTIVE MAINTENANCE WAS UPDATED TO INCLUDE A THOROUGH CLEANING OF ALL ROLLERS. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 1113442 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THERE IS FOREIGN MATERIAL INSIDE THE PRODUCT PACKAGING. PER EMAIL: DURING OUR MANUFACTURING PROCESS IT WAS DISCOVERED THAT 22 EACH OF ITEM 930815NS HAD FOREIGN MATERIAL INSIDE THE PRODUCT PACKAGING. THIS INCLUDED BLACK SPECS, WOOD LOOKING PIECES AND SOME OTHER STRINGY MATERIAL. LOT NUMBER AFFECTED WAS 1113442 EXP 4/2024. MOST RECENT PO# IS 367090 SEE PICTURES BELOW OF A FEW EXAMPLES. ANY HELP WITH THIS ISSUE IS GREATLY APPRECIATED

    Additional Manufacturer Narrative · 1

    IMDRF ANNEX E CODE HEALTH EFFECT: CLINICAL CODE: (B)(4) NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. IMDRF ANNEX F CODE HEALTH EFFECT: IMPACT CODE: (B)(4) NO PATIENT INVOLVEMENT. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: (B)(4) DEVICE CONTAMINATION SHIPPING/ MANUFACTURING. (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MATERIAL NO.: 930815NS BATCH NO.: 1113442. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THERE IS FOREIGN MATERIAL INSIDE THE PRODUCT PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184032 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 1113442

    Patients

    Seq Age Sex Outcome Treatment
    1 Other