BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11327987 · Received February 15, 2021

    Report

    Report Number
    3004932373-2021-00053
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Date of Event
    February 3, 2021
    Report Date
    February 5, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO SAMPLES OR PHOTOS ARE AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, BD IS UNABLE TO VERIFY THE REPORTED ISSUE OR DEFINED A ROOT CAUSE AT THIS TIME. PRODUCTION RECORD REVIEW WAS UNABLE TO BE COMPLETED AS NO BATCH/LOT INFORMATION WAS PROVIDED. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    MATERIAL NO.: 930815. BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THERE WAS ORANGE ON THE BACKSIDE OF THE LABEL. PER EMAIL: I RECEIVED A CALL FROM A CUSTOMER WHO DESCRIBED THAT THERE WAS "A LOT OF ORANGE ON THE LABEL ON THE BACKSIDE" OF THE CHLORAPREP APPLICATOR. CONTACT DETAILS ARE BELOW. NAME: [OMITTED]. CALL BACK NUMBER: [OMITTED]. EMAIL ADDRESS: [OMITTED]. FACILITY: [OMITTED]. BD PRODUCT #/CATALOG REF #? 930815. LOT #? UNKNOWN. SAMPLES? 5 AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224930 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other