MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 2L: 5.5FR X 15CM; MIDLINE CATHETER

Catalog Number	PR-41552-BAS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the patient has been carrying a midline catheter since (b)(6) 2025.On (b)(6) 2025, a call was received from the nursing assistant staff.Upon evaluating the device, it was confirmed that the catheter was properly stabilized with a transparent dressing and showed no displacement.However, leakage was observed at the insertion site during irrigation of the white lumen, and there was no blood return through the catheter."pdp." reported that the guidewire was bent and presented resistance when attempting to advance it; another identical unit was used." there was no patient harm or injury.The patient's current condition is reported as "fine".Associate mdr numbers include: 9680794-2025-01006 and 9680794-2025-01043.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the patient has been carrying a midline catheter since (b)(6) 2025.On (b)(6) 2025, a call was received from the nursing assistant staff.Upon evaluating the device, it was confirmed that the catheter was properly stabilized with a transparent dressing and showed no displacement.However, leakage was observed at the insertion site during irrigation of the white lumen, and there was no blood return through the catheter."pdp." reported that the guidewire was bent and presented resistance when attempting to advance it; another identical unit was used." there was no patient harm or injury.The patient's current condition is reported as "fine".Associate mdr numbers include: 9680794-2025-01006.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one video for analysis.The video shows a leaking catheter.The guidewire is not pictured in the video; therefore, the complaint of kinked guide wire was not confirmed by the video.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause catheter component damage or breakage.If placement damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The ifu also states, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage".Without the device to evaluate, 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 PI MIDLINE 2L: 5.5FR 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: 23704959
• Report Number: 9680794-2025-01043
• Device Sequence Number: 18809754
• Product Code: PND
• UDI-Device Identifier: 10801902136586
• UDI-Public: (01)10801902136586(11)240907(17)260531(10)33F24J0081(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 05/31/2026
• Device Catalogue Number: PR-41552-BAS
• Device Lot Number: 33F24J0081
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2024
• 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