MAUDE Adverse Event Report: Arrow International LLC ARROW AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-VPSB
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction

• Brand Name: ARROW 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: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50831695
• Report Number: 9680794-2026-00687
• Device Sequence Number: 10050550
• Product Code: PWR
• UDI-Device Identifier: 10801902208603
• UDI-Public: (01)10801902208603(11)260611(17)270930(10)33F26E0232
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/23/2026

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 Catalogue Number: DLX-45541-VPSB
• Device Lot Number: 33F26E0232
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2026
• 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
• Patient Sex: Unknown