BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 10474761 · Received August 31, 2020

    Report

    Report Number
    3004932373-2020-00027
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    July 31, 2020
    Report Date
    November 19, 2020
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    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 OR A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. PRODUCT RECORD REVIEW WERE REVIEWED FOR LOT 0081954 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. RECORDS INDICATE THAT THE REVIEWED BATCH RECORD PASSED ALL THE IN-PROCESS INSPECTIONS. THIS IS ONLY COMPLAINT THAT HAS BEEN RECEIVED FOR THE REPORTED DEFECT AND LOT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PARTICULATE WAS FOUND. LOTS AFFECTED: 0081954 AND UNKNOWN

    Additional Manufacturer Narrative · 1

    (B)(6) 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. LOTS AFFECTED: 0081954 AND UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937052 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC MULTIPLE LOTS AFFECTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other