BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 13661261 · Received March 3, 2022

    Report

    Report Number
    3004932373-2022-00063
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 3, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINED A DEFINITIVE ROOT CAUSE AT THIS TIME. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 1177228 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. IF A SAMPLE OR PHOTO BECOMES AVAILABLE, BD WILL RE-OPEN THE RECORD AND INVESTIGATE ACCORDINGLY. NO FURTHER ACTION WILL BE TAKEN. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CHLORAPREP AMPOULE SHATTERED. VERBATIM: CHLORAPREP *NOT ENOUGH INFO PROVIDED* WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING THAT THE CHLORAPREP AMPOULE SHATTERED. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. EXTERNAL # (B)(4). PV RESPONSE: TUE 2/15/2022 3:04 AM: KINDLY NOTE THAT THERE WILL BE NO LATE SUBMISSION, BECAUSE INITIAL REPORT (DOIN: (B)(6) 2021) FOR WHICH THE ADDITIONAL CASE WAS OPENED YESTERDAY ((B)(4)) WAS CONSIDERED AS NON-SERIOUS WITHOUT PATIENT IDENTIFIERS AND AS SUCH DOES NOT REQUIRE SUBMISSION TO ANY REGULATORY AUTHORITY. BASED ON THE ANSWERS ON FU QUESTIONS RECEIVED FOR THE CASE (B)(4) (LRD: (B)(6) 2022), CASE WAS UPGRADED TO SERIOUS AND AS SUCH REQUIRES SUBMISSION (DUE DATE: (B)(6) 2022). FOR ADDITIONALLY OPENED CASE ((B)(4)) FOLLOW-UP WILL BE OPENED AS WELL (LRD: (B)(6) 2022) BASED ON THE ABOVE MENTIONED ANSWERS FOR THE CASE (B)(4), BECAUSE THE REPORTER STATED THAT BOTH PATIENTS EXPERIENCED THE EXACT SAME EVENT, AND THE CASE WILL ALSO BE SUBMITTED ON TIME (DUE DATE: (B)(6) 2022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167528 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 1177228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other