BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS KIT 6FR X 16CM

    MDR report key: 20314377 · Received September 26, 2024

    Report

    Report Number
    9680904-2024-00020
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 5, 2024
    Report Date
    November 14, 2024
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403076114
    PMA / PMN Number
    NA
    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

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A2101. PATIENT PROBLEM CODE: F27. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO AND ONE SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO LABEL WAS OBSERVED ON THE PACKAGE OF KIT; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. 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 KIT WAS SENT WITHOUT ANY LABELING ON THE KIT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ISSUE - PIG TRAY KILLEEN TX.. PIG1260K KIT WAS SENT WITHOUT ANY LABELING ON THE KIT. FOLLOW-UP: CUSTOMER RESPONSE ON (B)(6 2024. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE ITEM DID NOT HAVE ANY LABELING. NO REFERENCE NUMBER, LOT NUMBER OR PRODUCT INFORMATION. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? BEFORE, SO IT WAS NOT USED. 3. WHAT WAS THE IMPACT TO THE PATIENT? NO. CUSTOMER RESPONSE ON (B)(6) 2024. AS PER THE ATTACHED PHOTO SAMPLE LOT NUMBER AND MATERIAL NUMBER IS AVAILABLE. COULD YOU PLEASE CONFIRM IF THIS LOT NUMBER IS RELATED TO DEFECTIVE LABELING ISSUE PRODUCT? - I DO NOT KNOW IF THAT IS THE SAME LOT NUMBER. THE ITEM ON THE LEFT WAS FOUND IN THE BIN NEXT TO THE ONE ON THE RIGHT. IT IS POSSIBLE THAT THEY ARE THE SAME LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT KIT WAS SENT WITHOUT ANY LABELING ON THE KIT. RCC RECEIVED A COMPLAINT VIA EMAIL. ISSUE - PIG TRAY KILLEEN TX PIG1260K KIT WAS SENT WITHOUT ANY LABELING ON THE KIT. FOLLOW-UP: CUSTOMER RESPONSE ON SEP 10, 2024 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE ITEM DID NOT HAVE ANY LABELING. NO REFERENCE NUMBER, LOT NUMBER OR PRODUCT INFORMATION. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? BEFORE, SO IT WAS NOT USED. 3. WHAT WAS THE IMPACT TO THE PATIENT? NO CUSTOMER RESPONSE ON (B)(6) 2024. AS PER THE ATTACHED PHOTO SAMPLE LOT NUMBER AND MATERIAL NUMBER IS AVAILABLE. COULD YOU PLEASE CONFIRM IF THIS LOT NUMBER IS RELATED TO DEFECTIVE LABELING ISSUE PRODUCT? - I DO NOT KNOW IF THAT IS THE SAME LOT NUMBER. THE ITEM ON THE LEFT WAS FOUND IN THE BIN NEXT TO THE ONE ON THE RIGHT. IT IS POSSIBLE THAT THEY ARE THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709639 SAFE-T-CENTESIS KIT 6FR X 16CM THORACENTESIS TRAY PXI CAREFUSION, INC UNKNOWN 10885403076114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other