BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE- STEP HI- LITE ORANGE

    MDR report key: 11768208 · Received May 4, 2021

    Report

    Report Number
    3004932373-2021-00224
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    July 9, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. FOLLOW UP E MDR ASROKA 7/9/2021.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815 BATCH NO.: 0328213. IT WAS REPORTED THAT THE CHLORAPREP EXPLODED CAUSING THE GLASS TO FALL ON THE PATIENT AND ONE EXPLODED IN THE PACK.

    Additional Manufacturer Narrative · 1

    (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.: 0328213. IT WAS REPORTED THAT THE CHLORAPREP EXPLODED CAUSING THE GLASS TO FALL ON THE PATIENT AND ONE EXPLODED IN THE PACK. PER PHONE CALL: CUSTOMER STATED ALL LOTS ARE HAVING ISSUES. ONE EXPLODED IN THE PACK, THE 2 WERE OUT OF PACK AND EXPLODED AND GLASS GOT ONTO THE PATIENT. ONE PATIENT WAS AWAKE THE OTHER WAS ASLEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664511 CHLORAPREP ONE- STEP HI- LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0328213

    Patients

    Seq Age Sex Outcome Treatment
    1