BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11640409 · Received April 9, 2021

    Report

    Report Number
    3004932373-2021-00189
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 18, 2021
    Report Date
    July 21, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FACILITY REPORTED MULTIPLE FOREIGN MATTER OBSERVANCES OF BLACK SPOTS. THE FAILURE MODE OF FOREIGN MATTER ¿ SPOTS (BLACK SPECS) WAS CONFIRMED BY SAMPLES AND PHOTOGRAPH RECEIVED FOR ANALYSIS. ONE OF THE SOURCES OF FM BLACK SPECS IS THE PRINTER OF THE PACKAGING LIDDING. BD UPDATED CURRENT WEEKLY PREVENTIVE MAINTENANCE TO INCLUDE A THOROUGH CLEANING OF ALL ROLLERS (ADDED IDLE ROLLERS ON THE PRINTER MACHINE, MARK ANDY EQUIPMENT). THE PHOTOGRAPH PROVIDED ALSO SHOWED A BLACK FIBROUS MATERIAL FROM THE OLD LABCOATS USED BY THE ASSOCIATES AND MECHANICS. NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THE LOTS REFERENCED. A CAPA IS OPENED TO ADDRESS FM & HAIR WITH ONE OF THE ACTIONS ITEMS WITH NEW ORANGE OR LIGHT BLUE ANTI-STATOC LABCOATS WHICH ARE LESS PRONE TO RELEASE DARK BLUE FIBERS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. FOLLOW UP EMDR (B)(4). H3 OTHER TEXT: SEE BELOW PLEASE.

    Description of Event or Problem · 0

    MATERIAL NO: 930815. BATCH NO: 0350121, 1015563, 0362253, 0347346. IT WAS REPORTED THAT MOST ISSUES THE CUSTOMER IS EXPERIENCING CONSIST OF SMALL SPOTS OF CHLORAPREP AND BLACK SPOTS. A FEW HAVE ALSO HAD LEAKAGE INTO THE HANDLE AND SPONGE, EVENT DESCRIPTION PER ATTACHED EMAIL FROM BD REP STATES: WE ARE EXPERIENCING A HIGH AMOUNT OF PACKAGING ISSUES WITH BD 930815. MOST ISSUES CONSIST OF SMALL SPOTS OF CHLORAPREP AND BLACK SPOTS (SEE ATTACHED). A FEW HAVE ALSO HAD LEAKAGE INTO THE HANDLE AND SPONGE, THIS PRODUCT HAS ALREADY BEEN SENT BACK TO BD. ALL PACKAGING SEEMS TO BE WELL SEALED. 18 EACH -- LOT# : 0350121. 23 EACH -- LOT# : 1015563. 13 EACH -- LOT#: 0362253. 8 EACH -- LOT#: 0347346. EVENT DESCRIPTION PER ATTACHED EMAIL FROM MEDLINE STATES: INJURIES OR ADVERSE EVENT: NO. ITEM: 930815. QUANTITY AFFECTED: 8 EACH. SERIAL/LOT NUMBER: NA. REPORTED ISSUE: PACKAGING ISSUE.

    Additional Manufacturer Narrative · 1

    (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: 930815, BATCH NO: 0350121, 1015563, 0362253, 0347346. IT WAS REPORTED THAT MOST ISSUES THE CUSTOMER IS EXPERIENCING CONSIST OF SMALL SPOTS OF CHLORAPREP AND BLACK SPOTS. A FEW HAVE ALSO HAD LEAKAGE INTO THE HANDLE AND SPONGE. EVENT DESCRIPTION PER ATTACHED EMAIL FROM BD REP STATES: WE ARE EXPERIENCING A HIGH AMOUNT OF PACKAGING ISSUES WITH BD 930815. MOST ISSUES CONSIST OF SMALL SPOTS OF CHLORAPREP AND BLACK SPOTS. A FEW HAVE ALSO HAD LEAKAGE INTO THE HANDLE AND SPONGE, THIS PRODUCT HAS ALREADY BEEN SENT BACK TO BD. ALL PACKAGING SEEMS TO BE WELL SEALED. 18 EACH -- LOT# : 0350121. 23 EACH -- LOT# : 1015563. 13 EACH -- LOT#: 0362253. 8 EACH -- LOT#: 0347346. EVENT DESCRIPTION FROM MEDLINE STATES: INJURIES OR ADVERSE EVENT: NO. ITEM: 930815. QUANTITY AFFECTED: 8 EACH. SERIAL/LOT NUMBER: NA. REPORTED ISSUE: PACKAGING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537714 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0347346

    Patients

    Seq Age Sex Outcome Treatment
    1 Other