BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11956208 · Received June 8, 2021

    Report

    Report Number
    3004932373-2021-00277
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    April 29, 2021
    Report Date
    June 8, 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
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE MODE WAS CONFIRMED BASED ON SAMPLES RECEIVED FOR ANALYSIS SHOWING A SHALL PINHOLE APPROXIMATELY 1/16 OF INCH IN DIAMETER ON THE FOAM TIP. THE FOAM TIP IS WELDED UNTO THE APPLICATOR PLASTIC BODY BY ULTRASONICALLY WELDING WHICH CREATES HEAT BY FRICTION MELTING THE PLASTIC RIM AND NOVENETTE WHICH BOND TOGETHER. ON RARE OCCASIONS THE OVER WELDING (FRICTION) IN A SMALL, CONCENTRATED AREA OCCURS WHICH MAY CAUSE THE FOAM TO MELT UNEVENLY THUS CREATING THE PINHOLE. THIS MAY OCCUR DUE TO A DIRTY ULTRASONIC WELDING HOLD. THE PINHOLE OBSERVED DOES NOT AFFECT THE PRODUCT FUNCTION/ PERFORMANCE DUE TO THE SMALL SIZE, NO PLASTIC EXPOSED AND LIMITED OVERWELDING WITH NO DRIPPING OR POOLING OBSERVED ON APPLICATORS TESTED; THUS, THE PRODUCT IS FUNCTIONAL. NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT 1040320. BD WILL CONTINUE TO TRACK AND TREND. (B)(4). EMDR SUBMISSION.

    Description of Event or Problem · 1

    MATERIAL NO.: 930815, BATCH NO.: 1040320. IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE IS A PINHOLE ON THE SPONGE. PER EMAIL: SC2021000602 136710 930815, PO: 951343092 AND 951344891. TOTAL QUANTITY: 4,575 EACHES. A PINHOLE ON THE SPONGE PART OF THE COMPONENT. WE HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF MEDLINE ITEM NUMBER (136710) - CHLORAPREP APP 26ML ORANGE (REF. 930815), WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF OUR KITS. IT WAS FOUND THAT THERE IS A PINHOLE ON THE SPONGE PART OF THE COMPONENT. WE WANT TO ENSURE THAT YOU ARE AWARE OF THIS ISSUE AND THAT WE DO REQUIRE A RESPONSE. PICTURES HAVE BEEN ATTACHED FOR YOUR REFERENCE OF THE NONCONFORMANCE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859167 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1040320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other