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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the patient has been carrying a midline catheter since on (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.
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).The actual device was not returned; however, the customer provided one video for analysis.The complaint of leaking from the insertion site was confirmed by the video.When the proximal extension line was being flushed, a leak from the insertion site was noted.No damage to the catheter could be observed in the video; however, a complete visual inspection to determine the cause of the leak 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, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over-pressurizing an occluded or partially occluded catheter." 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: 23704976
• Report Number: 9680794-2025-01006
• Device Sequence Number: 10720180
• 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: 12/18/2025
• 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