BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 12394680 · Received August 31, 2021

    Report

    Report Number
    3004932373-2021-00419
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 31, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, 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.

    Description of Event or Problem · 1

    MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE LITERATURE CASE THAT THE CHLORHEXIDINE HAD LOWER BACTERIAL COUNTS AFTER PREPARATION COMPARED WITH IODINE. PER FINAL CIOMS: DESCRIBE REACTION(S) CONTINUED: CHLORHEXIDINE VERSUS IODINE FOR VAGINAL PREPARATION BEFORE HYSTERECTOMY: A RANDOMIZED CLINICAL TRIAL, FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY; 2021. CASE REFERENCE NUMBER (B)(4) IS A LITERATURE CASE, TITLE AS STATED ABOVE, IDENTIFIED ON 10-AUG-2021, AND CONCERNS. MULTIPLE FEMALE PATIENTS. THE AIM OF THIS STUDY WAS TO COMPARE THE EFFECTIVENESS OF CHLORHEXIDINE VERSUS IODINE IN DECREASING VAGINAL BACTERIAL COUNTS. THE PARTICIPANTS UNDERGOING TOTAL HYSTERECTOMY VIA VAGINAL OR LAPAROSCOPIC APPROACH WERE RANDOMIZED TO 4 % CHLORHEXIDINE OR 10 % IODINE FOR PRESURGICAL VAGINAL PREPARATION. SWABS WERE COLLECTED FROM THE VAGINAL MUCOSA BEFORE, THEN 30, 60, AND 90 MINUTES AFTER PREPARATION. PRIMARY OUTCOME WAS THE NUMBER OF POSITIVE CULTURES (MORE THAN AND EQUAL TO 5,000 BACTERIA) AT 90 MINUTES. THE SECONDARY OUTCOMES INCLUDED THE PRESENCE OF SELECTED PATHOGENS, POSTOPERATIVE COMPLICATIONS, AND INFECTIONS. THE SAMPLE SIZE OF 71 PER ARM WAS CALCULATED USING P = 0.05, 80 % POWER, AND ANTICIPATING A 22 % DIFFERENCE IN POSITIVE CULTURES. BETWEEN MAY 2018 AND AUGUST 2019, 85 PARTICIPANTS WERE RANDOMIZED. BASELINE BACTERIAL COUNTS WERE SIMILAR IN BOTH GROUPS. CHLORHEXIDINE DEMONSTRATED A LOWER PERCENTAGE OF POSITIVE CULTURES AT 90 MINUTES (47.6 % VS 85.4 %; ODDS RATIO, 10.6; P = 0.001). IN ADDITION, THE MEDIAN BACTERIAL COUNT IN THE CHLORHEXIDINE GROUP WAS SIGNIFICANTLY LOWER THAN THE IODINE GROUP (3,000 VS 24,000 COLONY-FORMING WITS, P LESS THAN 0.001) AT 90 MINUTES. ONLY STAPHYLOCOCCUS SHOWED SIGNIFICANT DIFFERENCES IN GROWTH AT 90 MINUTES ON INDIVIDUAL PATHOGEN ANALYSIS. FIVE PARTICIPANTS (25 COLONY-FORMING UNITS (CFU) %) FROM THE CHLORHEXIDINE GROUP VERSUS 19 PARTICIPANTS (54.3 %) FROM THE IODINE GROUP (P = 0.035) REACHED 5,000 CFUS. POOLED COUNTS OF THE NINE MOST COMMON SPECIES WERE SIGNIFICANTLY LOWER IN THE CHLORHEXIDINE GROUP AT 90 MINUTES WITH A MEDIAN COUNT OF ZERO (0, 49,000) AND MEDIAN COUNT OF 4,000 (0, 49,000) THE IODINE GROUP (P LESS THAN 0.001). THIS DIFFERENCE REMAINED SIGNIFICANT AT 60 MINUTES AND 30 MINUTES. NO SURGICAL SITE INFECTIONS WERE IDENTIFIED IN EITHER GROUP DURING THE 30-DAY POSTOPERATIVE PERIOD, AND THERE WERE NO REPORTED ADVERSE REACTIONS TO EITHER SOLUTION. AUTHOR'S COMMENT: ''CHLORHEXIDINE RESULTED IN SUBSTANTIALLY LOWER BACTERIAL COUNTS AFTER PREPARATION COMPARED WITH IODINE. GYNAECOLOGIC SURGEONS MAY CONSIDER SWITCHING TO 4 % CHLORHEXIDINE FOR VAGINAL PREPARATION BEFORE HYSTERECTOMY. STUDY SUGGESTS THAT 4 % CHLORHEXIDINE IS SUPERIOR TO 10 % IODINE AT REDUCING BACTERIAL LOAD WHEN USED FOR PRESURGICAL PREPARATION OF THE VAGINA. SWITCHING TO CHLORHEXIDINE FOR VAGINAL SCRUB BEFORE HYSTERECTOMY MAY REDUCE WOMEN'S RISK OF MORBIDITY CAUSED BY INFECTION THROUGH A REDUCED BACTERIAL LOAD. THE ADOPTION OF SYSTEM WIDE POLICIES USING CHLORHEXIDINE FOR VAGINAL PREPARATION MAY PROVE TO BE AN IMPORTANT STEP IN MOVING TOWARD THE ULTIMATE GOAL OF ZERO POSTOPERATIVE INFECTIONS.''

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291445 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other