BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP

    MDR report key: 23595272 · Received November 19, 2025

    Report

    Report Number
    9680794-2025-01021
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    July 2, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902208603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION D.1.-BRAND NAME CORRECTED TO AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP. SECTION D.4.-CATALOG# CORRECTED TO DLX-45541-VPSB. SECTION D.4.-LOT# CORRECTED TO 33F24F1032. SECTION D.4.-UDI# CORRECTED TO (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)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ON (B)(6) 2025, PATIENT (B)(6) , A 22-YEAR-OLD FEMALE, PRESENTED TO THE CLINIC FOR SCHEDULED DEVICE PLACEMENT. SUBSEQUENTLY, ON (B)(6) 2025, THE SAME DAY THE DEVICE WAS REMOVED, THE PATIENT EXPERIENCED A NON-SERIOUS ADVERSE EVENT CHARACTERIZED BY 'LOCAL SITE PAIN'. THE CATHETER WAS REPLACED." ADDITONAL INFORMAION RECIEVED STATES "THE PICC TEAM EVALUATED THE PATIENT AND AFTER RECIEVING THE RESULTS FROM THE ULTRASOUND THAT SHOWED A BLOOD CLOT IN THE CEPHALIC VEIN, IN CONJUNCTION WITH THE PATIENT COMPLAINING OF INSERTION SITE PAIN, THE DECISON WAS MADE TO REMOVE THE PICC AND REPLACE IT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ON (B)(6) 2025, PATIENT 103-031, A 22-YEAR-OLD FEMALE, PRESENTED TO THE CLINIC FOR SCHEDULED DEVICE PLACEMENT. SUBSEQUENTLY, ON (B)(6) 2025, THE SAME DAY THE DEVICE WAS REMOVED, THE PATIENT EXPERIENCED A NON-SERIOUS ADVERSE EVENT CHARACTERIZED BY 'LOCAL SITE PAIN'. THE CATHETER WAS REPLACED." ADDITONAL INFORMAION RECIEVED STATES "THE PICC TEAM EVALUATED THE PATIENT AND AFTER RECIEVING THE RESULTS FROM THE ULTRASOUND THAT SHOWED A BLOOD CLOT IN THE CEPHALIC VEIN, IN CONJUNCTION WITH THE PATIENT COMPLAINING OF INSERTION SITE PAIN, THE DECISON WAS MADE TO REMOVE THE PICC AND REPLACE IT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494142 AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 33F24F1032 10801902208603

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Unknown NOT REPORTED