MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-VPSB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
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".
Additional Manufacturer Narrative
(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.
Event or Problem Description
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".

• Brand Name: AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23595272
• Report Number: 9680794-2025-01021
• Device Sequence Number: 15747749
• Product Code: FOZ
• UDI-Device Identifier: 10801902208603
• UDI-Public: (01)10801902208603(11)241122(17)260227(10)33F24F1032(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2026
• Device Catalogue Number: DLX-45541-VPSB
• Device Lot Number: 33F24F1032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 103 KG