BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11910777 · Received May 31, 2021

    Report

    Report Number
    3004932373-2021-00266
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Date of Event
    April 12, 2021
    Report Date
    August 10, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    YOUR FACILITY PROVIDED A PHOTO TO AID IN OUR QUALITY ENGINEER'S INVESTIGATION. WITH THE PHOTO PROVIDED, BD WAS ABLE TO VERIFY THE FAILURE MODE AS THE END CAP WAS DETACHED FROM THE APPLICATOR BODY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 1041625 AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING FOR END CAP FAILURE. THE ROOT CAUSE IS ATTRIBUTED TO THE EQUIPMENT STATION FOR THE END CAP PLACEMENT UNTO THE APPLICATOR BODY. CORRECTIVE ACTIONS WERE INITIATED WHICH LED TO BD CONDUCTING A VOLUNTARY RECALL ON CERTAIN LOTS OF THE CHLORAPREP HI-LITE ORANGE 26 ML APPLICATOR. BD HAS CONFIRMED THAT SOME OF THE PRODUCT, WHICH INCLUDED THIS LOT, HAD AN APPLICATOR END CAP THAT WAS IMPROPERLY SECURED DURING THE MANUFACTURING PROCESS WHICH RESULTED IN BROKEN GLASS DROPPING OUT OF THE APPLICATOR. YOUR FACILITY SHOULD HAVE RECEIVED A RECALL NOTIFICATION FOR THIS FAILURE, AND IT IS ALSO ATTACHED TO THIS EMAIL. PLEASE ENSURE THAT YOUR FACILITY COMPLETES THE CUSTOMER RESPONSE FORM ASSOCIATED WITH THE RECALL AND FOLLOWS THE DIRECTIONS PROVIDED. BD RECOGNIZES THAT CUSTOMERS PLACE THEIR TRUST IN OUR PRODUCTS, AND WE STRIVE TO EXCEED THE EXPECTATIONS OF EVERY CUSTOMER. YOUR FEEDBACK IS ESSENTIAL TO OUR MISSION TO IMPROVE THE PRODUCTIVITY AND SAFETY OF HEALTH CARE GLOBALLY. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AMPOULE WAS BROKEN UPON OPENING THE STERILE PACKAGING. PER RESPONSE EMAIL: THE SHAFT WAS CRACKED BY THE RN CIRCULATOR, SHE PAINTED THE EXTREMITY, AND WHILE SHE WAS HOLDING THE LEG UP TO DRY, SHE NOTICED SHATTERED GLASSES AND THE BROKEN AMPULE ON TOP OF THE BED BELOW THE RAISED LEG. THE RN IS SPECULATING THAT THE END CAP WAS MISSING OR IT CAME LOOSE- SHE SEARCHED AND FOUND NONE. THE RN USED 3 MORE WANDA WITH SAME LOT NO¿S WITH NO IDENTIFIED DEFECT THE NURSE NOTICED THAT THE AMPULE IN CHLORAPREP WAS BROKEN UPON OPENING THE STERILE PACKAGE. NO PATIENT WAS HARMED

    Additional Manufacturer Narrative · 1

    PR (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

    IT WAS REPORTED THAT THE AMPOULE WAS BROKEN UPON OPENING THE STERILE PACKAGING. PER RESPONSE EMAIL: THE SHAFT WAS CRACKED BY THE RN CIRCULATOR, SHE PAINTED THE EXTREMITY, AND WHILE SHE WAS HOLDING THE LEG UP TO DRY, SHE NOTICED SHATTERED GLASSES AND THE BROKEN AMPULE ON TOP OF THE BED BELOW THE RAISED LEG. THE RN IS SPECULATING THAT THE END CAP WAS MISSING OR IT CAME LOOSE- SHE SEARCHED AND FOUND NONE. THE RN USED 3 MORE WANDA WITH SAME LOT NO¿S WITH NO IDENTIFIED DEFECT . THE NURSE NOTICED THAT THE AMPULE IN CHLORAPREP WAS BROKEN UPON OPENING THE STERILE PACKAGE. NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807176 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1041625

    Patients

    Seq Age Sex Outcome Treatment
    1 Other