BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP

    MDR report key: 11613685 · Received April 5, 2021

    Report

    Report Number
    3004932373-2021-00169
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 23, 2021
    Report Date
    September 7, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP EMDR (B)(4). BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO PHYSICAL SAMPLE WAS PROVIDED PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR MATERIAL NO.: 260299NSB BATCH NO.: 0160547 WAS REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE.

    Description of Event or Problem · 0

    MATERIAL NO.: 260299NSB BATCH NO.: 0160547. IT WAS REPORTED SHARDS OF GLASS CAME OUT OF THE APPLICATOR AND CUT THE PATIENT. OUR INFUSION TEAM FOUND SHARDS OF GLASS COMING OUT OF ONE OF THE APPLICATORS AND CUT A PATIENT. I DO NOT KNOW THE PARTICULAR PRODUCT#, AS IT WAS PART OF A KIT, BUT BELOW IS A PICTURE OF IT. THIS WAS A PART OF THE TRINITY STERILE IV START KIT MFR CAT# 50667. I WILL ALSO BE NOTIFYING TRINITY STERILE ABOUT THIS. WE WERE UNABLE TO GET A PRODUCT NUMBER OF THE TRAY, BUT HERE ARE THE LOT NUMBERS IN THAT PAR: LOT#'S 600002, 600003, AND 600004.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO.: 260299NSB, BATCH NO.: 0160547. IT WAS REPORTED SHARDS OF GLASS CAME OUT OF THE APPLICATOR AND CUT THE PATIENT. OUR INFUSION TEAM FOUND SHARDS OF GLASS COMING OUT OF ONE OF THE APPLICATORS AND CUT A PATIENT. I DO NOT KNOW THE PARTICULAR PRODUCT#, AS IT WAS PART OF A KIT, BUT BELOW IS A PICTURE OF IT. THIS WAS A PART OF THE TRINITY STERILE IV START KIT MFR CAT# 50667. I WILL ALSO BE NOTIFYING TRINITY STERILE ABOUT THIS. WE WERE UNABLE TO GET A PRODUCT NUMBER OF THE TRAY, BUT HERE ARE THE LOT NUMBERS IN THAT PAR: LOT#'S 600002, 600003, AND 600004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512605 CHLORAPREP ONE STEP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 0160547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other