MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number	PR-41541-BAS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " around day 3 or 4 after a successful insertion, the midline starts leaking at the insertion site when saline/fluids are being pushed through.This is happening with 4 in patient and 1 outpatient.The line is removed when this issue happens.The vat had the opportunity to push saline through the removed midline and they noticed that the saline was coming out the distal end of the midline on an angle, almost out to the side.It's a single lumen so no side skives.They were using for hydration x 2 patients and antibiotics for others." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2026-00037, 9680794-2026-00038, 9680794-2026-00039, 9680794-2026-00040.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that " around day 3 or 4 after a successful insertion, the midline starts leaking at the insertion site when saline/fluids are being pushed through.This is happening with 4 in patient and 1 out patient.The line is removed when this issue happens.The vat had the opportunity to push saline through the removed midline and they noticed that the saline was coming out the distal end of the midline on an angle, almost out to the side.It's a single lumen so no side skives.They were using for hydration x 2 patients and antibiotics for others." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2026-00037, 9680794-2026-00038, 9680794-2026-00039, 9680794-2026-00040, and 9680794-2026-00041.

• Brand Name: ARROW AGBA PI MIDLINE 1L: 4.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• 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: 23973814
• Report Number: 9680794-2026-00041
• Device Sequence Number: 10704103
• Product Code: PND
• UDI-Device Identifier: 10801902136579
• UDI-Public: (01)10801902136579(11)250328(17)270131(10)33F25A0087(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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
• Device Catalogue Number: PR-41541-BAS
• Device Lot Number: 33F25A0087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2025
• 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