BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM)

    MDR report key: 20265159 · Received September 20, 2024

    Report

    Report Number
    9680794-2024-00919
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    April 9, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    PMA / PMN Number
    K042126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). UDI IS NOT AVAILABLE AS THE CORRECT LOT# WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "A 51-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH OVARIAN TUMOR WAS CALLED BY THE NURSE ON DUTY AND REQUESTED ASSISTANCE TO DISCONNECT THE PICC CATHETER EQUIPMENT, A FRACTURE WAS EVIDENCED WHEN THE EQUIPMENT WAS REMOVED, THE FRACTURE WAS BROKEN, THE PROXIMAL LUMEN WAS LEFT DISABLED AND IT WAS LEFT THROUGH ANOTHER DISTAL LUMEN PERMEABLE, PASSING PARENTERAL NUTRITION AT 72.5 CC/H PER INFUSION PUMP. THE PATIENT REPORTED THAT THE PORT CONNECTOR HAD BEEN TAMPERED WITH, FORCE APPARENTLY CAUSED THE RUPTURE. THERE WAS NO OTHER REPORTED PATIENT HARM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "A 51-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH OVARIAN TUMOR WAS CALLED BY THE NURSE ON DUTY AND REQUESTED ASSISTANCE TO DISCONNECT THE PICC CATHETER EQUIPMENT, A FRACTURE WAS EVIDENCED WHEN THE EQUIPMENT WAS REMOVED, THE FRACTURE WAS BROKEN, THE PROXIMAL LUMEN WAS LEFT DISABLED AND IT WAS LEFT THROUGH ANOTHER DISTAL LUMEN PERMEABLE, PASSING PARENTERAL NUTRITION AT 72.5 CC/H PER INFUSION PUMP. THE PATIENT REPORTED THAT THE PORT CONNECTOR HAD BEEN TAMPERED WITH, FORCE APPARENTLY CAUSED THE RUPTURE. THERE WAS NO OTHER REPORTED PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222145 ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM) CATHETER, INTRAVASCULAR, THER LJS ARROW INTERNATIONAL LLC 14F23A0245

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female NOT REPORTED| NOT REPORTED