BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP HI LITE ORANGE

    MDR report key: 11266718 · Received February 2, 2021

    Report

    Report Number
    3004932373-2021-00018
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 24, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    89 SAMPLES WITH THE MATERIAL NUMBER 930415 AND LOT NUMBER 0135287 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT 52 OF THE 89 SAMPLES HAD A BLACK STAIN; THEREFORE, THE INCIDENT COULD BE VERIFIED. THOUGH A LOT NUMBER WAS NOT ORIGINALLY REPORTED, A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE LOT NUMBER OF THE SAMPLES RECEIVED WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. VISUAL INSPECTION OF 50 RETAINED SAMPLES WAS PERFORMED AND NO ISSUES WERE OBSERVED. BASED ON THE INVESTIGATION, THE ROOT CAUSE IS RELATED TO PRINTER HEADS TINT LEAKING WHEN THE PRINTER STATION IS DISABLED AND NOT IN USE. A CHANGE HAS BEEN INITIATED TO UPDATE MANUFACTURING PROCEDURE SO THAT THE PRINTER HEADS FROM THE PRINTER STATION ARE REMOVED WHEN NOT BEING USED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE IS FOREIGN MATTER EMBEDDED IN THE PACKAGING MATERIAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE IS FOREIGN MATTER EMBEDDED IN THE PACKAGING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166236 CHLORAPREP ONE-STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other