BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE- STEP HI LITE ORANGE

    MDR report key: 11768230 · Received May 4, 2021

    Report

    Report Number
    3004932373-2021-00225
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    YOUR 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. YOUR FACILITY SHOULD HAVE RECEIVED A RECALL NOTIFICATION FOR THIS FAILURE, AND IT ALSO ATTACHED TO THIS EMAIL. PLEASE ENSURE THAT YOUR FACILITY COMPLETES THE CUSTOMER RESPONSE FORM ASSOCIATED WITH THE RECALL AND PROPERLY DISCARDS ANY AFFECTED PRODUCT. BD WILL REPLACE ALL DISCARDED APPLICATORS WITH UNAFFECTED BD PRODUCT . 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 SECTION.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815, BATCH NO.: UNKNOWN. IT WAS REPORTED THE BACK END OF THE APPLICATOR CAME OFF CAUSING THE GLASS TO BREAK. BACK OF APPLICATOR OFF AND GLASS VIALS BROKEN IN CHP 26ML. BROKEN GLASSDANGEROUS TO CUSTOMER AND PATIENT.

    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.: UNKNOWN. IT WAS REPORTED THE BACK END OF THE APPLICATOR CAME OFF CAUSING THE GLASS TO BREAK. BACK OF APPLICATOR OFF AND GLASS VIALS BROKEN IN CHP 26ML. BROKEN GLASS DANGEROUS TO CUSTOMER AND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670607 CHLORAPREP ONE- STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1028759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other