BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12336517 · Received August 18, 2021

    Report

    Report Number
    3004932373-2021-00382
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    March 6, 2021
    Report Date
    September 15, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    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 930700LN 0303523 WAS REVIEWED AND THERE ARE NO DEFECTS REPORTED RELATED TO "FOREIGN MATERIAL" DURING ROUTINE IN-PROCESS INSPECTIONS DURING THE PACKAGING OF THE LOT.A DEFINITE ROOT CAUSE CAN'T BE IDENTIFIED WITHOUT AN ACTUAL SAMPLE OR A PICTURE OF THE DEFECT. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE PACKAGING OF THE PRODUCT. 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 TRENDS. H3 OTHER TEXT : PLEASE SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930700 BATCH NO.: 0303523. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE DEVICE HAD PARTICULATE. PER REPORT: PARTICULATE.

    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 BY THE DISTRIBUTOR THAT THE DEVICE HAD PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233214 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0303523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other