BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS KIT 6FR X 16CM

    MDR report key: 14396786 · Received May 13, 2022

    Report

    Report Number
    9680904-2022-00023
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    November 16, 2021
    Report Date
    May 13, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403076114
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: PATIENT PROBLEM CODE: (B)(6). (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: THREE PHOTOS AND TEN PHYSICAL SAMPLES OF LOT 0001405396 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE NEEDLE IS NOT FULLY INSIDE THE CATHETER. A DIMENSIONAL INSPECTION WAS PERFORMED AND IN NINE OUT OF THE TEN SAMPLES RETURNED THE MEASUREMENTS FOR THE NEEDLE WERE OUT OF SPEC. AN OUT SPEC NEEDLE IN THE UPPER SPEC WOULD LEAD TO A MATING ISSUE 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 0001405396 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. BASED ON THE QUALITY TEAM'S INVESTIGATION, A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THESE DEFECTS. 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 THAT HEALTH PROFESSIONAL RECEIVED A LOT OF CATHETERS THAT WILL NOT FEED OVER THE NEEDLES. VERBATIM: "...RECEIVED A LOT OF CATHETERS THAT WILL NOT FEED OVER THE NEEDLES. WE HAVE OPENED 3 PACKAGES AND THEY ARE ALL THE SAME." "...THE PROBLEM THEY ARE EXPERIENCING IS THAT THE NEEDLE WILL NOT FIT THROUGH THE CATHETER, SO THEY HAVE TO OPEN A NEW TRAY UNTIL THEY CAN GET A NEEDLE TO FIT INTO A CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395306 SAFE-T-CENTESIS KIT 6FR X 16CM THORACENTESIS TRAY PXI CAREFUSION, INC PIG1260K 0001405396 10885403076114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other