BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11876776 · Received May 25, 2021

    Report

    Report Number
    3004932373-2021-00253
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 27, 2021
    Report Date
    August 17, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS ARE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINED ROOT CAUSE. A PRODUCTION RECORD REVIEW WAS COMPLETED AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. NO FURTHER ACTIONS IS 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 THAT THE PREP LEAKED OUT AND THROUGH THE PACKAGE. PER CUSTOMER RESPONSE: I NO LONGER HAVE THE ITEM SO I CAN¿T ANSWER YOUR QUESTION ON THAT. THANKS FOR GETTING BACK TO ME, I HAD THE ITEM BUT DO NOT HAVE NOW, I APOLOGIZE FOR NOT KEEPING THE PRODUCT IN QUESTION. PER COMPLAINT DETAILS: I AM REPORTING A CHLORAPREP THAT WAS BROUGHT TO MY ATTENTION FROM A STAFF MEMBER. THE PREP LEAKED OUT AN THROUGH THE PACKAGE. I FILLED OUT AN ARC ON THIS ITEM.

    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 THAT THE PREP LEAKED OUT AND THROUGH THE PACKAGE. PER COMPLAINT DETAILS: I AM REPORTING A CHLORAPREP THAT WAS BROUGHT TO MY ATTENTION FROM A STAFF MEMBER. THE PREP LEAKED OUT AN THROUGH THE PACKAGE. I FILLED OUT AN ARC ON THIS ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773942 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1013956

    Patients

    Seq Age Sex Outcome Treatment
    1 Other