BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORA/PARA TRAY, 5FR, NON-VALVED

    MDR report key: 20048044 · Received August 23, 2024

    Report

    Report Number
    1625685-2024-00098
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 5, 2024
    Report Date
    November 14, 2024
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403284748
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A1801. PATIENT PROBLEM CODE: F26.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE TRAY SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A SMALL PIECE OF CORRUGATE DEBRIS WAS OBSERVED, ON THE OUTSIDE OF THE WRAP. IT WOULD HAVE BEEN ENCLOSED WITHIN THE STERILE PACKAGE; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001555079 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. AWARENESS TRAINING HAS BEEN PERFORMED WITH THE ASSEMBLY TEAM TO RAISE AWARENESS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT WHEN THEY OPENED THE PACK, IT WAS A BROWN SPOT ON THE INSIDE OF THE PACKAGE. VERBATIM: THE ITEM WE HAVE IS CAT. OTP5000, AND WHEN THE PACK WAS OPENED IT WAS A BROWN SPOT ON THE INSIDE OF THE PACKAGE 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER 0001555079 2. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? I DO HAVE THE SAMPLE OF THE PACK WE CAN SEND. THE SAMPLE IS CURRENTLY AT OUR 1900 SOUTH AVE. LOCATION. IF YOU EMAIL ME A COPY OF THE SHIPPING LABEL I CAN PACK IT AND SEND IT TO WHERE IT NEEDS TO GO. BD REP RESPONSE RECEIVED ON 16-AUG-2024 1. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF YES, WHAT WAS THE IMPACT TO THE PATIENT? NO 2. IS THERE A PHOTO AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? NO. THEY ARE SENDING THE PRODUCT BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT WHEN THEY OPENED THE PACK, IT WAS A BROWN SPOT ON THE INSIDE OF THE PACKAGE. VERBATIM: THE ITEM WE HAVE IS CAT. OTP5000, AND WHEN THE PACK WAS OPENED IT WAS A BROWN SPOT ON THE INSIDE OF THE PACKAGE. 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER 0001555079. 2. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? I DO HAVE THE SAMPLE OF THE PACK WE CAN SEND. THE SAMPLE IS CURRENTLY AT OUR 1900 SOUTH AVE. LOCATION. IF YOU EMAIL ME A COPY OF THE SHIPPING LABEL I CAN PACK IT AND SEND IT TO WHERE IT NEEDS TO GO. BD REP RESPONSE RECEIVED ON 16-AUG-2024. 1. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF YES, WHAT WAS THE IMPACT TO THE PATIENT? NO. 2. IS THERE A PHOTO AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? NO. THEY ARE SENDING THE PRODUCT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380682 THORA/PARA TRAY, 5FR, NON-VALVED THORACENTESIS TRAY PXI CAREFUSION, INC 0001555079 10885403284748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other