BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE S

    MDR report key: 11870487 · Received May 24, 2021

    Report

    Report Number
    3004932373-2021-00248
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 10, 2021
    Report Date
    August 24, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY MEMORIAL REGIONAL MEDICAL CENTER. PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS. NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. A DEVICE HISTORY REVIEW WAS COMPLETED FOR BATCH/LOT 0304792 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. IF SAMPLES, PHOTOS OR ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, THIS RECORD WILL BE RE-OPENED AND PROCESSED ACCORDINGLY. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE GLASS BROKE THROUGH THE APPLICATOR BARREL AND CUT THE HEALTH PROFESSIONAL. PER EMAIL: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: YES. MEDLINE REFERENCE: 200442593. ITEM: 930815. QUANTITY AFFECTED: 1 EACH. SERIAL/LOT NUMBER: (B)(6). PO #: 4513834399. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: PER CUSTOMER: I HAD A RN CRACK A CHLORAPREP TODAY DO PREPARE TO PREP THE PATIENT AND THE GLASS AMPULE WENT THROUGH THE PLASTIC AND CUT HER HAND. I HAVE THE PRODUCT AND IT'S PACKAGE IN MY OFFICE IN A BIOHAZARD BAG IF YOU NEED IT. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

    Additional Manufacturer Narrative · 1

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE GLASS BROKE THROUGH THE APPLICATOR BARREL AND CUT THE HEALTH PROFESSIONAL. PER EMAIL: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: YES. MEDLINE REFERENCE: (B)(4). ITEM: 930815 QUANTITY AFFECTED: 1 EACH. SERIAL/LOT NUMBER: (B)(4). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: PER CUSTOMER: I HAD A RN CRACK A CHLORAPREP TODAY DO PREPARE TO PREP THE PATIENT AND THE GLASS AMPULE WENT THROUGH THE PLASTIC AND CUT HER HAND. I HAVE THE PRODUCT AND IT'S PACKAGE IN MY OFFICE IN A BIOHAZARD BAG IF YOU NEED IT. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767692 CHLORAPREP ONE STEP HI-LITE ORANGE S 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0304792

    Patients

    Seq Age Sex Outcome Treatment
    1 Other