BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12861307 · Received November 23, 2021

    Report

    Report Number
    3004932373-2021-00499
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 9, 2021
    Report Date
    February 7, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    UDI-DI
    27613203022112
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE DEFECT. BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIAL NO.: 260407I, BATCH NO.: 1080995. IT WAS REPORTED THAT WHEN CHLORAPREP WAS CLICKED TO START CLEANING DONOR'S ARM, A PIECE OF GLASS FROM THE VIAL FELL ONTO THE DONORS ARM CAUSING A SUPERFICIAL CUT. VERBATIM: HELLO,WE HAVE HAD AN ARM CLEANING INCIDENT WHERE ONE OF OUR OPERATORS CLICKED A CHLORAPREP TO START TO CLEAN THE DONOR'S ARM PRIOR TO VENEPUNCTURE AND A PIECE OF GLASS FROM THE VIAL INSIDE FELL ONTO THE DONORS ARM CAUSING A SUPERFICIAL CUT. CHLORAPREP LOT NUMBER 1080995, EXP 03/2024KIND REGARDS.

    Description of Event or Problem · 0

    MATERIAL NO.: 260407I, BATCH NO.: 1080995. IT WAS REPORTED THAT WHEN CHLORAPREP WAS CLICKED TO START CLEANING DONOR'S ARM, A PIECE OF GLASS FROM THE VIAL FELL ONTO THE DONORS ARM CAUSING A SUPERFICIAL CUT. HELLO,WE HAVE HAD AN ARM CLEANING INCIDENT WHERE ONE OF OUR OPERATORS CLICKED A CHLORAPREP TO START TO CLEAN THE DONOR'S ARM PRIOR TO VENEPUNCTURE AND A PIECE OF GLASS FROM THE VIAL INSIDE FELL ONTO THE DONORS ARM CAUSING A SUPERFICIAL CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758187 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1080995 27613203022112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other