BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP HI LITE ORANGE

    MDR report key: 11639735 · Received April 9, 2021

    Report

    Report Number
    3004932373-2021-00187
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 11, 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
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR 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

    MATERIAL NO.: 930815, BATCH NO.: 0328213. IT WAS REPORTED THAT THE END CAP FELL OFF AND THE GLASS VIAL BROKE ON THE FLOOR. PER EMAIL: LOT #: 0328213 WHAT¿S BREAKING: CHLORAPREP 26 ML STICK. THE END CAP SEEMS TO BE POORLY GLUED. I HAVE WITNESSED TWO SITUATIONS¿AS SOON AS THE CHLORAPREP IS PICKED UP, THE END CAP FALLS OFF AND THE VIALS CONTAINING THE CHG SOLUTION FALL OUT AND BREAK ON THE FLOOR; OR WHEN THE LEVER IS COMPRESSED TO CRUSH THE VIALS INSIDE OF THE HANDLE, THE CAP THEN SEEMS TO ¿BLOW OFF¿ OF THE END OF THE STICK. I DO NOT CURRENTLY HAVE AN IMAGE OF AN AFFECTED PRODUCT. DATES OF OCCURRENCE WERE (B)(6) 2022. YES, I HAVE A SAMPLE THAT I CAN SEND FOR INVESTIGATION. WE WILL SHIP IT FROM: NO ONE WAS INJURED AS A RESULT OF THIS DEFECT. IT DID RESULT IN A SLIGHT DELAY OF TREATMENT AS THE NURSE WOULD HAVE TO BREAK OUT OF HER STERILE GLOVES, RETRIEVE ANOTHER CHLORAPREP, REGLOVE AND THEN PREP THE OPERATIVE SITE.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: (B)(4) NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. IMDRF ANNEX F CODE HEALTH EFFECT: IMPACT CODE: (B)(4) NO PATIENT INVOLVEMENT OR (B)(4). IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: (B)(4) DETACHMENT OF DEVICE OR DEVICE COMPONENT ((B)(4)).

    Description of Event or Problem · 1

    MATERIAL NO.: 930815 BATCH NO.: 0328213. IT WAS REPORTED THAT THE END CAP FELL OFF AND THE GLASS VIAL BROKE ON THE FLOOR. PER EMAIL: LOT #: 0328213. WHAT¿S BREAKING: CHLORAPREP 26 ML STICK. THE END CAP SEEMS TO BE POORLY GLUED. I HAVE WITNESSED TWO SITUATIONS¿AS SOON AS THE CHLORAPREP IS PICKED UP, THE END CAP FALLS OFF AND THE VIALS CONTAINING THE CHG SOLUTION FALL OUT AND BREAK ON THE FLOOR; OR WHEN THE LEVER IS COMPRESSED TO CRUSH THE VIALS INSIDE OF THE HANDLE, THE CAP THEN SEEMS TO ¿BLOW OFF¿ OF THE END OF THE STICK. I DO NOT CURRENTLY HAVE AN IMAGE OF AN AFFECTED PRODUCT. DATES OF OCCURRENCE WERE (B)(6) 2021, (B)(6) 2021, (B)(6). YES, I HAVE A SAMPLE THAT I CAN SEND FOR INVESTIGATION. WE WILL SHIP IT FROM: NO ONE WAS INJURED AS A RESULT OF THIS DEFECT. IT DID RESULT IN A SLIGHT DELAY OF TREATMENT AS THE NURSE WOULD HAVE TO BREAK OUT OF HER STERILE GLOVES, RETRIEVE ANOTHER CHLORAPREP, REGLOVE AND THEN PREP THE OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538707 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 Other