BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT ACCESS NEEDLE

    MDR report key: 19070749 · Received April 9, 2024

    Report

    Report Number
    19070749
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    November 27, 2023
    Report Date
    December 4, 2023
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    UDI-DI
    801741047466
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    6 LINE FAILURES: MODEL 142075: IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) LINE CRACKED AT THE HUB OF THE TUBING CONNECTING TO THE HUB AS A MEDICATION WAS INFUSING THROUGH HER LINE. HER INFUSION WAS STOPPED, AND BLOOD WAS DRAWN BACK 2ML DUE TO POSSIBLE CONTAMINATION. DEVICE WAS NOT SAVED. MODEL 142075: IVAD LINE WAS NOTED TO BE LEAKING BLOOD OUT ONTO THE SHEETS. UPON INSPECTION, IT WAS NOTED THAT THE LINE WAS CRACKED AT THE HUB. LINE WAS PROMPTLY CLAMPED AND IVAD WAS DE-ACCESSED. PORT SITE WAS THEN CLEANED AND RE-ACCESSED USING STERILE TECHNIQUE. BROKEN TUBING WAS SAVED. MODEL 142075: CRACK IN IVAD EXTENSION, REPLACED. MODEL 142075: UPON START OF OBTAINING LABS FROM PATIENTS' SINGLE LUMEN IVAD, I LAID OUT ALL OF MY EQUIPMENT. I CLEANED THE HUB AND ATTACHED THE CLOSED SYSTEM PER PROTOCOL. I THEN UNCLAMPED THE IVAD AND THE CLOSED SYSTEM IN ORDER TO FLUSH WITH SALINE. WHEN I FLUSHED, I HEARD WHAT SOUNDED LIKE FLUID. UPON CLOSER INSPECTION, I SAW THAT THE SALINE I FLUSHED COMING OUT THROUGH A CRACK IN THE TUBING RIGHT UNDER THE NEEDLE HUB. NO FLUIDS WERE RUNNING PRIOR. THE LINE HAD BEEN HEPARIN LOCKED PRIOR TO THE START OF THE LAB DRAW. THE LAB DRAW WAS STOPPED, THE HUB WAS CLEANED AND RECAPPED. MODEL 142075: REGISTERED NURSE (RN) NOTICED BLOOD WAS LEAKING FROM IV TUBING. RN STOPPED THE INFUSION PUMP WHICH HAD CEFEPIME INFUSING AT THE TIME OF THE EVENT. RN DISCONNECTED THE INTRAVENOUS LINE (IV) TUBING FROM THE IVAD AND FLUSHED THE IVAD WITH NORMAL SALINE. RN NOTICED THE HOLE IN THE IVAD TUBING WAS JUST BEFORE THE HUB WHICH CONNECTS TO THE MICROCLAVE. RN HEPARIN LOCKED THE IVAD AND DE-ACCESSED FROM PATIENT. THE CHARGE NURSE AND ANOTHER NURSE FROM THE FLOOR ASSISTED IN ACCESSING THE PATIENT WITH A NEW IVAD PORT. DEVICE WAS SAVED. MODEL LH-0037: TUBING CONNECTED TO THE PORT NEEDLE CRACKED. THE CRACK WAS DIRECTLY ABOVE THE HARD PLASTIC PART (ABOVE WHERE YOU CONNECT THE CAP). THE TUBING WAS CLAMPED ABOVE THE CRACK AND THERE WAS NOTHING INFUSING IN THE LINE. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, PORT ACCESS NEEDLE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607188 PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. 0142075 801741047466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown