BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 12111541 · Received July 2, 2021

    Report

    Report Number
    3004932373-2021-00313
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 19, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR PR (B)(4). PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 270480 LOT NUMBER 0143401WAS 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 FAILURE MODE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS. FAILURE MODE WAS NOT CONFIRMED SINCE NO SAMPLE OR PHOTO WAS RECEIVED FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO POST MANUFACTURING HANDLING OR TRANSPORTATION DURING SHIPPING, WHICH CAN PROVIDE ENOUGH FORCE TO ACTIVATE AND BREAK THE GLASS AMPOULE. DUE TO THE NATURE OF GLASS IT IS POSSIBLE TO HAVE AN ACTIVATED APPLICATOR AND/OR BROKEN AMPOULE IF THE APPLICATOR UNDERGOES EXCESSIVE HANDING. AMPOULES ARE MADE FROM GLASS TUBING ONION SKIN BOROSILICATE TYPE I GLASS WHICH ARE DESIGN TO BREAK WHEN PRESSURE IS APPLIED TO ACTIVATE APPLICATOR. 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 · 0

    MATERIAL NO.: 270480 BATCH NO.: 0143401. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THE SPONGE REMAINS DRY AFTER ACTIVATION. PER EMAIL: WE ARE RUNNING A TRIAL WITH THE NATIONAL BLOOD SERVICE IN THEIR TRANSFER FROM THE 260407I APPLICATORS TO THE 270480 APPLICATORS AND IN THE TRIAL OF 1,000 APPLICATORS THEY FOUND:- - AFTER ACTIVATION, SPONGE THE REMAINS DRY , 2ND WAND HAS TO BE USED, 52 DEVICES SO FAR HAVE BEEN IDENTIFIED (CURRENTLY IF REQUIRED FOR INVESTIGATION) , SITE WHERE VALIDATION IS BEING DONE NORMALLY DOES 1300-1400 VP'S PER MONTH THE BATCH NUMBER FOR THE 270480 IS 0143401. THE APPLICATORS ARE AVAILABLE AND I CAN HAVE THEM COLLECTED IF NECESSARY BUT THEY HAVE BEEN CONFIRMED AS PRIMED I.E. GLASS AMPOULE BROKEN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 270480. BATCH NO.: 0143401. IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THE SPONGE REMAINS DRY AFTER ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005157 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0143401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other