BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLINOIS (TJ) NEEDLE ASPIRATION 18GA

    MDR report key: 17877627 · Received October 5, 2023

    Report

    Report Number
    1625685-2023-00102
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 28, 2023
    Report Date
    November 30, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FMI
    UDI-DI
    10885403043819
    PMA / PMN Number
    K930217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 8993984 FOLLOW-UP EMDR FOR DEVICE EVALUATION: TWO PHOTOS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, WE CAN CONFIRM THAT THE ASSEMBLY CAME APART, EXPOSING THE NEEDLE, WHICH DAMAGED THE PACKAGING. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001493219 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. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND AWARENESS TRAINING WILL BE PROVIDED. 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

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0205. PATIENT PROBLEM CODE: F27.

    Description of Event or Problem · 0

    NEEDLE UNSHEATHED IN PACKAGING. WE HAVE HAD A SAFETY CONCERN REGARDING A CAREFUSION ILLINIOS STERNAL/ILIAC NEEDLE 18G X 3" REF TIN3018 BATCH 0001493219 EXP 30/09/27 THE ASPIRATION NEEDLE HAD BECOME UNSHEATHED FROM THE SAFETY TIP AND WAS POKING OUT THE SIDE OF THE PACKET. THIS OCCURRED INSIDE THE CARDBOARD BOX PACKAGING. IT COULD HAVE CAUSED A NEEDLE STICK INJURY. I HAVE PHOTOS, IF YOU REQUIRE THEM. MARIE DIXON PER FOLLOWUP: NO PATIENT INVOLVEMENT, IT WAS FOUND BY HAEMATOLOGY CONSULTANT AND REGISTRAR. NO NEEDLESTICK INJURY OCCURRED AS THEY NOTICED IT AS THEY WERE PULLING IT OUT OF THE BOX, SO NOT REPORTED, OTHER THAN TO LET ME KNOW TO NOTIFY YOU. THE PHYSICAL NEEDLE WAS DISCARDED IMMEDIATELY INTO A SHARPS BIN TO PREVENT ANYBODY FROM HARM.

    Description of Event or Problem · 0

    NEEDLE UNSHEATHED IN PACKAGING. WE HAVE HAD A SAFETY CONCERN REGARDING A CAREFUSION ILLINIOS STERNAL/ILIAC NEEDLE 18G X 3" REF (B)(4) BATCH 0001493219 EXP 30/09/27 THE ASPIRATION NEEDLE HAD BECOME UNSHEATHED FROM THE SAFETY TIP AND WAS POKING OUT THE SIDE OF THE PACKET. THIS OCCURRED INSIDE THE CARDBOARD BOX PACKAGING. IT COULD HAVE CAUSED A NEEDLE STICK INJURY. I HAVE PHOTOS, IF YOU REQUIRE THEM. MARIE DIXON PER FOLLOWUP: NO PATIENT INVOLVEMENT, IT WAS FOUND BY HAEMATOLOGY CONSULTANT AND REGISTRAR. NO NEEDLESTICK INJURY OCCURRED AS THEY NOTICED IT AS THEY WERE PULLING IT OUT OF THE BOX, SO NOT REPORTED, OTHER THAN TO LET ME KNOW TO NOTIFY YOU. THE PHYSICAL NEEDLE WAS DISCARDED IMMEDIATELY INTO A SHARPS BIN TO PREVENT ANYBODY FROM HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343658 ILLINOIS (TJ) NEEDLE ASPIRATION 18GA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CAREFUSION, INC 0001493219 10885403043819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other