BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 10475098 · Received August 31, 2020

    Report

    Report Number
    3004932373-2020-00035
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    July 31, 2020
    Report Date
    November 18, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS AVAILABLE FOR EVALUATION. UNFORTUNATELY, AS A RESULT, THE FAILURE MODE COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DEFINED. PRODUCT RECORD REVIEW WAS COMPLETED FOR LOT NUMBERS 0006142, 0041225 AND 0041224 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THESE LOTS. THIS IS THE ONLY COMPLAINT THAT HAS BEEN RECEIVED FOR THE REPORTED DEFECT AND LOTS. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PARTICULATE WAS FOUND. LOT AFFECTED: 0006142, 0041225 AND 0041224

    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 PARTICULATE WAS FOUND. LOT AFFECTED: 0006142, 0041225 AND 0041224.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939414 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION, INC MULTIPLE LOTS AFFECTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other