BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11772238 · Received May 4, 2021

    Report

    Report Number
    3004932373-2021-00231
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 14, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FACILITY DID NOT PROVIDE PHOTOS/SAMPLES TO AID IN OUR QUALITY ENGINEER¿S INVESTIGATION. 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. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 930815, BATCH NO.: 0323213. IT WAS REPORTED THE APPLICATORS CRACKED AND GLASS WENT ALL ON THE FLOOR AND PATIENT. PER EMAIL:THE FOLLOWING COMPLAINT WAS RECEIVED TODAY OVER THE PHONE: MATERIAL INFO: CATALOG: 930815; LOT: 0323213. SAMPLES UNAVAILABLE. DESCRIPTION OF EVENT: 3 TOTAL CHLORAPREPS CRACKED AND GLASS WENT ALL OVER PATIENT/FLOOR. 2 EVENTS ON 12TH (PATIENT/FLOOR), AND 1 EVENT YESTERDAY (B)(6) 2021 GLASS WENT ON FLOOR. KNOWN DATES OF EVENTS: 2 ON (B)(6) 2021; 1 ON (B)(6) 2021. ADVERSE EVENT: NONE; NO PATIENT HARM- ABLE TO SAFELY REMOVE AND CLEAN OFF PATIENT.

    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.: 0323213. IT WAS REPORTED THE APPLICATORS CRACKED AND GLASS WENT ALL ON THE FLOOR AND PATIENT. PER EMAIL:THE FOLLOWING COMPLAINT WAS RECEIVED TODAY OVER THE PHONE: MATERIAL INFO: CATALOG: 930815 , LOT: 0323213, SAMPLES UNAVAILABLE. DESCRIPTION OF EVENT: 3 TOTAL CHLORAPREPS CRACKED AND GLASS WENT ALL OVER PATIENT/FLOOR. 2 EVENTS ON 12TH (PATIENT/FLOOR), AND 1 EVENT YESTERDAY (B)(6) 2021 GLASS WENT ON FLOOR. KNOWN DATES OF EVENTS: 2 ON (B)(6) 2021. ADVERSE EVENT: NONE; NO PATIENT HARM- ABLE TO SAFELY REMOVE AND CLEAN OFF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669327 CHLORAPREP ONE STEP HI LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0323213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other