BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 12354266 · Received August 23, 2021

    Report

    Report Number
    3004932373-2021-00409
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 27, 2021
    Report Date
    September 28, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLES SHOWS ORANGE DOTS ON THE FOAM TIP AND ON THE LIDDING. THIS VERIFIES THE REPORTED ISSUE. THE TYPE OF RED/ORANGE DYE IS ACCEPTABLE AROUND THE TINTED ORANGE PLEDGET AND ON THE BACK SIDE OF THE FOAM TIP BUT IS CONSIDERED A COSMETIC DEFECT WHEN THE ORANGE DYE IS ON THE FRONT OF THE FOAM TIP SCRUBBING SURFACE OR ON THE LIDDING. THE ORANGE DYE IS NOT OF FOREIGN MATTER ORIGIN, BUT IS AN INACTIVE INGREDIENT INHERIT IN THE PRODUCT BY DESIGN. THE ORANGE DYE POWDER MAY BE DISPERSED TO THE OUTSIDE OF THE APPLICATOR ON RARE OCCASIONS DURING THE ASSEMBLY, AND PACKAGING. ALSO, DURING THE STERILIZATION WHICH USES VAPOR (WATER), WHEN IN CONTACT WITH THE ORANGE DYE BRINGS OUT EXAGGERATES THE ORANGE COLOR INTENSITY. THE MOST PROBABLE ROOT CAUSE FOR ORANGE DYE AROUND THE TINTED PLEDGET IS THE EQUIPMENT, PROCESS AND/OR MATERIAL VARIABILITY INHERENT TO THE PROCESS AND DESIGN. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 9361584 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THESE LOTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. 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 ARE DOTS ON THE SPONGE. OUR OR IS NOW REJECTING MOST INDIVIDUAL 26ML CHLORAPREPS. THEY WERE REJECTING THOSE THAT THEY FOUND WITH DOTS BUT THEY ARE NOW REJECTING IF THEY ARE OF THAT SAME LOT NUMBER. WE WILL TRY ORDERING TO SEE IF WE CAN GET ANOTHER LOT NUMBER WITH A DIFFERENT RESULT. MY STAFF MEMBER RAISED THE CONCERN WHEN THEY GAVE HER ANOTHER STARS TODAY IN 3 BAGS THAT HAS THE QUANTITY AS 35ISH. I DON'T SEE INC21399249 IN THE SYSTEM YET. IT FEELS LIKE THIS IS GOING TO BE AN ISSUE UNLESS BD CAN CONFIRM THAT THESE SMALL DOTS ARE NOT IMPACTING STERILITY. IT IS VARIOUS NOW. LOT NUMBERS THAT HAVE BEEN RECORDED: 1124893, 1147596, 1151543, 0351280, 1124893, 9361584, 0357929, 1065310, 1089684. THESE SEEM TO HAVE THE SIMILAR PROBLEM AS THE ONES THAT I SENT BACK TODAY.

    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 FACILITY REPRESENTATIVE THAT THERE ARE DOTS ON THE SPONGE. OUR OR IS NOW REJECTING MOST INDIVIDUAL 26ML CHLORAPREPS. THEY WERE REJECTING THOSE THAT THEY FOUND WITH DOTS BUT THEY ARE NOW REJECTING IF THEY ARE OF THAT SAME LOT NUMBER. WE WILL TRY ORDERING TO SEE IF WE CAN GET ANOTHER LOT NUMBER WITH A DIFFERENT RESULT. MY STAFF MEMBER RAISED THE CONCERN WHEN THEY GAVE HER ANOTHER STARS TODAY IN 3 BAGS THAT HAS THE QUANTITY AS (B)(4). I DON'T SEE (B)(4) IN THE SYSTEM YET. IT FEELS LIKE THIS IS GOING TO BE AN ISSUE UNLESS BD CAN CONFIRM THAT THESE SMALL DOTS ARE NOT IMPACTING STERILITY. IT IS VARIOUS NOW. LOT NUMBERS THAT HAVE BEEN RECORDED: 1124893, 1147596, 1151543, 0351280, 1124893, 9361584, 0357929, 1065310, 1089684. THESE SEEM TO HAVE THE SIMILAR PROBLEM AS THE ONES THAT I SENT BACK TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250892 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 9361584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other