BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T PLUS THORACENTESIS/PARACENTESIS

    MDR report key: 19703245 · Received July 9, 2024

    Report

    Report Number
    1625685-2024-00069
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 29, 2024
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, DISCOLORATION OBSERVED, HOWEVER, IT IS UNCLEAR WHETHER THE DISCOLORATION AFFECTS ONLY THE CAP OR BOTH THE CAP AND THE VIAL; 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 0001557909 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. A QUALITY NOTIFICATION HAS BEEN SENT TO THE SUPPLIER 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.

    Additional Manufacturer Narrative · 0

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0407. PATIENT PROBLEM CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED THE FAR LEFT TUB HAD A DISCOLORATION ON IT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. UPON OPENING THE TRAY THE CUSTOMER NOTICED THE FAR LEFT TUB HAD A DISCOLORATION ON IT. DESCRIBE PATIENT / HCP / USER IMPACT - DID NOT USE THE TUBE AND OPENED ANOTHER KIT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED THE FAR LEFT TUB HAD A DISCOLORATION ON IT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. UPON OPENING THE TRAY THE CUSTOMER NOTICED THE FAR LEFT TUB HAD A DISCOLORATION ON IT. DESCRIBE PATIENT / HCP / USER IMPACT - DID NOT USE THE TUBE AND OPENED ANOTHER KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498096 SAFE-T PLUS THORACENTESIS/PARACENTESIS THORACENTESIS TRAY PXI CAREFUSION, INC 0001557909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other