BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 12055419 · Received June 23, 2021

    Report

    Report Number
    3004932373-2021-00301
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 11, 2021
    Report Date
    August 9, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE FACILITY DID PROVIDE PHOTOS/SAMPLES TO AID IN OUR QUALITY ENGINEER¿S INVESTIGATION. WITH THE SAMPLE, PROVIDED, BD WAS ABLE TO CONFIRM THE FAILURE MODE AS THE END CAP WAS DETACHED FROM THE APPLICATOR BODY. A DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES WAS NOTED DURING THE MANUFACTURING OF THIS LOT. 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. 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 BY THE DISTRIBUTOR THAT THE AMPOULE FELL OUT AND SHATTERED.

    Additional Manufacturer Narrative · 1

    (B)(4). PR (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.: 930815 BATCH NO.: 136710 IT WAS REPORTED BY THE DISTRIBUTOR THAT THE AMPOULE FELL OUT AND SHATTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944211 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1033869

    Patients

    Seq Age Sex Outcome Treatment
    1 Other