BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP FREPP

    MDR report key: 11884469 · Received May 26, 2021

    Report

    Report Number
    3004932373-2021-00258
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 11, 2021
    Report Date
    July 27, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR (B)(4) THE BATCH RECORD FOR PN 930299 LN 0343691 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO BROKEN AMPOULE DURING THE MANUFACTURING OF THIS LOT. THE BATCH RECORD FOR THE AMPOULE USED TO ASSEMBLE THE LOT WHICH IS PN 3-900900 LN 0307415 WAS ALSO REVIEWED TO SEE IF THE LOT HAD ANY ISSUES WITH LOW FILL OR BROKEN AMPOULE AND NO NON-CONFORMANCES WERE FOUND. BASED ON NO PHOTOGRAPH OR SAMPLE WAS RECEIVED FOR ANALYSIS FROM THE CUSTOMER, THE FAILURE MODE COULD NOT BE CONFIRMED. THE AMPOULE IS MADE OF GLASS AND IS DESIGNED TO BREAK AT A RELATIVELY LOW BREAK FORCE. WHEN PRESSURE IS APPLIED TO THE WINGS BY A PINCHING FORCE WITH THE FINGERS, THIS ACTIVATES THE APPLICATOR; BREAKING THE GLASS AMPOULE AND RELEASING THE CHLORAPREP SOLUTION ONTO THE FOAM TIP. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO POST MANUFACTURING HANDLING, WHICH CAN PROVIDE ENOUGH FORCE/IMPACT 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 HANDLING. WITHOUT THE ACTUAL SAMPLE A ROOT CAUSE CAN'T BE DETERMINE H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL NO.: 930299 , BATCH NO.: 0343691. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THE APPLICATORS ARE NOT MOISTENING OR STAYING MOIST LONG ENOUGH TO PROPERLY PREPARE PATIENT'S SKIN. DESCRIPTION: ED STAFF HAD BEEN USING THE 3ML CHLORAPREPS. DUE TO RECALLS/BACKORDERS SUBS WERE SUGGEST BY SUPPLY CHAIN AFTER WORKING WITH THE VENDOR BD. PER THE ED STAFF, THE REPLACEMENT CHLORAPREPS ARE NOT WORKING RIGHT. THEY ARE NOT MOISTENING (CONTAINING PRODUCT) OR STAY MOIST ENOUGH TO PROPERLY PREPARE SKIN FOR VENIPUNCTURE DRAW OF CULTURES (30 SEC TO 1 MINUTE OF SCRUB TIME). WENT THROUGH 6 TO DO 2 SETS OF BLOOD CULTURES WHERE 2 SHOULD BE SUFFICIENT. IS WASTEFUL, CAUSES PATIENT DISCOMFORT AND WILL LEAD TO CONTAMINATED BLOOD CULTURES.ED IS NOW USING THE 10 ML PRODUCT TO ACCOMPLISH THE SAME TASTE AS THE 3 ML ORIGINAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO.: 930299. BATCH NO.: 0343691. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THE APPLICATORS ARE NOT MOISTENING OR STAYING MOIST LONG ENOUGH TO PROPERLY PREPARE PATIENT'S SKIN. DESCRIPTION: ED STAFF HAD BEEN USING THE 3ML CHLORAPREPS. DUE TO RECALLS/BACKORDERS SUBS WERE SUGGEST BY SUPPLY CHAIN AFTER WORKING WITH THE VENDOR BD. PER THE ED STAFF, THE REPLACEMENT CHLORAPREPS ARE NOT WORKING RIGHT. THEY ARE NOT MOISTENING (CONTAINING PRODUCT) OR STAY MOIST ENOUGH TO PROPERLY PREPARE SKIN FOR VENIPUNCTURE DRAW OF CULTURES (30 SEC TO 1 MINUTE OF SCRUB TIME). WENT THROUGH 6 TO DO 2 SETS OF BLOOD CULTURES WHERE 2 SHOULD BE SUFFICIENT. IS WASTEFUL, CAUSES PATIENT DISCOMFORT AND WILL LEAD TO CONTAMINATED BLOOD CULTURES. ED IS NOW USING THE 10 ML PRODUCT TO ACCOMPLISH THE SAME TASTE AS THE 3 ML ORIGINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782578 CHLORAPREP ONE STEP FREPP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0343691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other