BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12354296 · Received August 23, 2021

    Report

    Report Number
    3004932373-2021-00410
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    August 11, 2021
    Report Date
    October 19, 2021
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE AVAILABLE FOR EVALUATION. SAMPLES WERE RECEIVED ACTIVATED WITH NO SOLUTION PRESENT IN THE AMPOULE. NO POSSIBLE ROOT CAUSE COULD BE DETERMINED BASED ON VISUAL EXAMINATION OF THESE SAMPLES RETURNED NOR COULD THE ADVERSE REACTION BE VERIFIED. RETENTION SAMPLES FOR PN 931490 LN 0140871 WERE VISUALLY EXAMINED AND THEY DID NOT PRESENT ANY DISCOLORATION THAT WOULD INDICATE THE PRESENCE OF MICROBIAL CONTAMINATION. IN ACCORDANCE WITH INTERNAL PROCEDURES, THE AMPOULES AND SOLUTION USED TO MANUFACTURE PN 931490 LN 010871 WERE SUBMITTED TO CHEMISTRY AND MICROBIAL TESTING AT THE TIME THE PRODUCTS WERE MANUFACTURED AND STERILIZED. CHEMISTRY AND MICROBIOLOGY TEST RESULTS FOR BOTH THE AMPOULE LOT AND SOLUTION LOT WERE WITHIN SPECIFICATION ENSURING CHG/IPA ASSAY, IMPURITY LEVELS AND SOLUTION STERILITY WERE WITHIN SPECIFICATIONS. IN ADDITION, THE CHG RAW MATERIAL USED IN THE SOLUTION WAS ALSO SUBMITTED TO CHEMISTRY TESTING PRIOR TO BEING USED IN MANUFACTURING AND TEST RESULTS ALSO SHOW THAT IT WAS WITHIN SPECIFICATION. THE BATCH RECORD FOR PN 931490 LN 0140871 WAS REVIEWED AND THERE WAS A NON-CONFORMANCE FOUND DURING THE ASSEMBLY OF THE LOT DURING ONE OF THE ROUTINE QA INSPECTIONS. THE NON-CONFORMANCE FOUND WAS RELATED TO FOREIGN MATERIAL. THE LOT WAS NOT REJECTED IN ACCORDANCE WITH OUR SAMPLING PLAN. THE LOT HAD A QUALITY NOTIFICATION OPENED DUE TO THE SUPPLIER ISSUE. THE SUPPLIER COMMUNICATED THAT THE SOLUTION LOT USED TO MANUFACTURE PN 9301490 LN 0140871 WAS POTENTIALLY AFFECTED BY A MICROBIAL CONTAMINATION. THE PRODUCT WAS PLACED ON HOLD AND A SITUATIONAL ANALYSIS WAS PERFORMED TO EVALUATE THE RISK OF THE POTENTIAL CONTAMINATION. THE RESULTS OF THE INVESTIGATION INDICATED THAT THE POSSIBILITY OF THE CONTAMINANT IS NONE DUE TO THE ABILITY OF IPA (ONE OF CHLORAPREP¿S INGREDIENTS) TO KILL BACTERIA THROUGH THE COAGULATION AND/OR DENATURING OF PROTEINS AND MACROMOLECULES, WHICH LEADS TO DISRUPTION OF CYTOPLASMIC INTEGRITY, CELL LYSIS, AND INTERFERENCE WITH CELLULAR METABOLISM. DUE TO THE NATURE OF THE INGREDIENTS IN CHLORAPREP, THE POTENTIAL FOR INFECTIOUS COMPLICATIONS DUE TO A POSSIBLE MICROBIAL CONTAMINATION IS NON-EXISTENT. THE DESIGN FAILURE MODE AND EFFECTS ANALYSIS WAS REVIEWED, AND THE RISK OF A SKIN REACTION IS CONSIDERED. POSSIBLE POTENTIAL CAUSES INCLUDE INCREASED CHG CONCENTRATION, INCREASED IPA CONCENTRATION, CHEMICAL SPECIFICATIONS DO NOT MEET REQUIREMENTS, INCREASED IMPURITY OR LEACHABLE CONCENTRATIONS. DUE TO THE NATURE OF CHLORAPREP INGREDIENTS IT MAY CAUSE ALLERGIC REACTIONS. INSTRUCTIONS FOR USE INCLUDE AN ALLERGY ALERT. THE ALERT READS ¿THIS PRODUCT MAY CAUSE A SEVERE ALLERGIC REACTION. SYMPTOMS MAY INCLUDE WHEEZING/DIFFICULTY BREATHING, SHOCK, FACIAL SWELLING, HIVES, RASH. IF AN ALLERGIC REACTION OCCURS, STOP USE AND SEEK MEDICAL HELP RIGHT AWAY. DO NOT USE ON PATIENTS ALLERGIC TO CHLORHEXIDINE GLUCONATE OR ANY OTHER INGREDIENT IN THIS PRODUCT¿. THERE WERE NO FINDINGS IN THE INVESTIGATION OF THE MANUFACTURING AND RELEASE PROCESSES OF PN 931490 LN 0140871 THAT WOULD SUGGEST A CAUSE FOR AN ADVERSE REACTION. NO FURTHER ACTIONS ARE REQUIRED. BD WILL CONTINUE TO TRACK AND TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THE PATIENT HAD AN ALLERGIC REACTION TO CHLORAPREP. PER EMAIL: IT HAS BEEN REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC REACTION TO CHLORAPREP. CUSTOMER HAS ADVISED THAT THE CONTAMINATED SAMPLE IS AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(6) 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 FACILITY REPRESENTATIVE THAT THE PATIENT HAD AN ALLERGIC REACTION TO CHLORAPREP. PER EMAIL: IT HAS BEEN REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC REACTION TO CHLORAPREP. CUSTOMER HAS ADVISED THAT THE CONTAMINATED SAMPLE IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251329 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG 0140871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other