BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG

    MDR report key: 22913359 · Received August 28, 2025

    Report

    Report Number
    9680794-2025-00767
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 5, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    PMA / PMN Number
    K113277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (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

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "WE HAVE HAD AN INCIDENT WHERE A PICC LINE HAS SPLIT APPROXIMATELY 3MM FROM HUB, WHEN IV CT CONTRAST WAS INJECTED. THE LINE HAD BEEN FLUSHED AND WAS ASPIRATING PRIOR TO CONNECTION. THE PICC WAS UNCLAMPED AT THE TIME OF CONTRAST INJECTION. THERE WERE NO KINKS EVIDENT IN THE PICC LINE PRIOR TO ACCESS. AFTER THE INCIDENT, THE LINE WAS IMMEDIATELY CLAMPED BELOW LEVEL OF THE SPLIT AND SECURED IN A STERILE DRESSING AND A LINE EXCHANGED PERFORMED AFTER CONSULTATION WITH RADIOLOGY REGISTRAR AND VASCULAR PHO." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "WE HAVE HAD AN INCIDENT WHERE A PICC LINE HAS SPLIT APPROXIMATELY 3MM FROM HUB, WHEN IV CT CONTRAST WAS INJECTED. THE LINE HAD BEEN FLUSHED AND WAS ASPIRATING PRIOR TO CONNECTION. THE PICC WAS UNCLAMPED AT THE TIME OF CONTRAST INJECTION. THERE WERE NO KINKS EVIDENT IN THE PICC LINE PRIOR TO ACCESS. AFTER THE INCIDENT, THE LINE WAS IMMEDIATELY CLAMPED BELOW LEVEL OF THE SPLIT AND SECURED IN A STERILE DRESSING AND A LINE EXCHANGED PERFORMED AFTER CONSULTATION WITH RADIOLOGY REGISTRAR AND VASCULAR PHO.". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519893 ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG CATHETER INTRAVASCULAR THERAPE LJS ARROW INTERNATIONAL LLC 33F24E0749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED