BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12336814 · Received August 18, 2021

    Report

    Report Number
    3004932373-2021-00385
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    January 28, 2021
    Report Date
    September 15, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    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

    FAILURE MODE IS NOT CONFIRMED SINCE NO EVIDENCE WAS PROVIDED BY CUSTOMER. THE BATCH RECORD FOR PN 930700 LN 0190176 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. NO FURTHER ACTION WILL BE TAKEN BASED ON A NEGATIVE TREND IS NOT OBSERVED AT THIS TIME. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930700NS, BATCH NO.: 0190176. 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. PER REPORT: PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236206 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 0190176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other