BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE-STEP

    MDR report key: 11261595 · Received February 1, 2021

    Report

    Report Number
    3004932373-2021-00016
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 18, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE AND PHOTO WERE AVAILABLE FOR EVALUATION. DURING ANALYSIS, IT WAS OBSERVED A PIECE OF PAPER INSIDE THE PACKAGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PAPER FOUND INSIDE THE PACKAGE WAS CONFIRMED TO BE PAPER USED FOR THE LIDDING OF THE PACKAGE. WHEN A PAPER ROLL IS BEING CHANGED, THE MACHINE MUST BE VERIFIED BY PRODUCTION PERSONNEL TO PREVENT PAPER TRIM BEING LEFT NEAR TO THE MACHINE CHAINS SINCE THIS CAN BE TRAPPED BY THE PACKAGING CONVEYOR CHAINS AND CONSEQUENTLY FALL INSIDE THE PACKAGING. THE MOST PROBABLE ROOT CAUSE IS FAILURE ON PACKAGING PROCESS AND/OR PREVENTIVE MEASURES DURING THE MANUFACTURING OF THE PRODUCT. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR LOT 0050733 REGARDING ITEM #931490 WERE REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS. AN AWARENESS SESSION WAS CONDUCTED TO THE PRODUCTION PERSONNEL. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF PAPER WAS FOUND IN THE PACKAGE OF UNUSED APPLICATOR.

    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

    MATERIAL NO.: 931490. BATCH NO.: 0050733. IT WAS REPORTED THAT A PIECE OF PAPER WAS FOUND IN THE PACKAGE OF UNUSED APPLICATOR. PER COMPLAINT FORM: REMAINING PRODUCTS IN THE BOX WERE CHECKED AND THERE WAS NO OTHER DEFECT OBSERVED. HAS THE COMPLAINANT REPORTED THE ISSUE AS A ADVERSE DRUG REACTION? PRODUCT COMPLAINT RECORD DETAIL: IT HAS BEEN REPORTED THAT THERE WAS A PIECE OF PAPER FOUND IN PACKAGE OF UNUSED APPLICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158778 CHLORAPREP ONE-STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other