BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP HI-LITE ORANGE

    MDR report key: 12337953 · Received August 18, 2021

    Report

    Report Number
    3004932373-2021-00398
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    February 25, 2021
    Report Date
    September 27, 2021
    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

    THE BATCH RECORD FOR PN 930815 LN 0290261 WAS REVIEWED AND THERE ARE NO DEFECTS REPORTED RELATED TO "FOREIGN MATERIAL" DURING ROUTINE IN-PROCESS INSPECTIONS DURING THE PACKAGING OF THE LOT. WITHOUT A PHYSICAL SAMPLE IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TREND FOLLOW UP EMDR (B)(4).

    Description of Event or Problem · 0

    MATERIAL NO.: 930815. BATCH NO.: 0290261. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE DEVICE WAS DIRTY/STAINED. PER REPORT: DIRTY/STAINED.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE DEVICE WAS DIRTY/STAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234294 CHLORAPREP ONE-STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0290261

    Patients

    Seq Age Sex Outcome Treatment
    1