BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11613382 · Received April 5, 2021

    Report

    Report Number
    3004932373-2021-00164
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    June 28, 2021
    Manufacturer
    CAREFUSION, INC
    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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE END CAP OF THE APPLICATOR CAME OFF DURING ACTIVATION CAUSING GLASS TO FALL OUT.

    Additional Manufacturer Narrative · 1

    (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

    MATERIAL NO.: 930815, BATCH NO.: 0327868. IT WAS REPORTED THE END CAP OF THE APPLICATOR CAME OFF DURING ACTIVATION CAUSING GLASS TO FALL OUT. PR 1 OF 2: THIS PR IS FOR DATE OF EVENT (B)(6) 2021 . PRODUCT# 930815: PRODUCT DESCRIPTION: APPLICATOR CHLORAPREP 26ML. LOT# 0327868. DESCRIPTION OF EVENT: CHLORAPREP PREP STICK WHEN SQUEEZED TO ACTIVATE AND BREAK THE TINCURE LOST THE REAR CAP. THIS SENT GLASS PARTICLES TOWARDS THE CIRCULATORS FACE AND ON THE STERILE FIELD. THIS MAY NOT BE AN ISOLATED EVENT. LAST WEEK A SIMILAR INCIDENT OCCURRED WHERE THE CAP CAME LOOSE BUT NO GLASS WAS PROJECTED. ALL PREP STICKS WITH THE SAME LOT NUMBER WILL BE SEQUESTERED FROM OUR ROOMS. SUSPECTED DEFECTIVE PRODUCT WAS SEQUESTERED AND IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513078 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC 0327868

    Patients

    Seq Age Sex Outcome Treatment
    1 Other