MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45552-VPSB
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picc nurse was placing picc line on patient using vps g4 when a blue bullseye showed on the screen but 20cm of catheter was out of the patient.After an x-ray, the picc tip of shown to be located at the subclavian vein.Picc nurse confirmed that the line was not in a artery.Patient was unharmed during the procedure." the patient's current condition is reported as "fine".
Event or Problem Description
It was reported "picc nurse was placing picc line on patient using vps g4 when a blue bullseye showed on the screen but 20cm of catheter was out of the patient.After an x-ray, the picc tip of shown to be located at the subclavian vein.Picc nurse confirmed that the line was not in a artery.Patient was unharmed during the procedure." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be performed as no sample was returned for analysis.The complainant provided a photograph of the patient case report.In the photograph, a bbe can be seen.There is no doppler signal displayed.Only one wave of the internal ecg signal is displayed.An assessment of this issue cannot be made based on the information provided.A device history record review performed on the stylet did not reveal any manufacturing related issues.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.

• Brand Name: ARROW AGBA PICC G4 STYLET: 2L 5.5FR 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: 21976414
• Report Number: 9680794-2025-00387
• Device Sequence Number: 7273192
• Product Code: LJS
• UDI-Device Identifier: 10801902208627
• UDI-Public: (01)10801902208627(11)240905(17)251231(10)33F24D0839(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: DLX-45552-VPSB
• Device Lot Number: 33F24D0839
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2024
• 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 Sex: Unknown