MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX55CM W/130CM HYDR NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35541-HPHNL
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 "picc kinked between hub with wingguard dressing and secure-a-cath".As a result, a new catheter was inserted.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "picc kinked between hub with wingguard dressing and secure-a-cath".As a result, a new catheter was inserted.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one single-lumen pi picc catheter for analysis.Signs of use in the form of biological material and medication were observed on the catheter.It was noted that the catheter body was trimmed at the 39 cm marking.The severed portion was not returned.Visual analysis revealed three kinks on the catheter body adjacent to the juncture hub.No other defects or anomalies were observed.The kinks in the catheter body were located 1 mm, 2 mm, and 5 mm from the juncture hub.The catheter body length measured 40.7 cm, which indicates that 15.16 cm - 16.44 cm of the catheter body was severed and not returned (per catheter product drawing.The outer diameter of the catheter body measured 0.056", which is within the specification limits of 0.054" - 0.057" per the catheter body extrusion product drawing.A lab inventory syringe filled with water was attached to the extension line and flushed.No resistance or blockages were encountered.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The returned catheter was threaded through a lab inventory guidewire (.018" diameter.The guidewire passed with little to no resistance.Performed per ifu statement, "thread catheter over guidewire and advance catheter over guidewire to final indwelling position using image guidance or fluoroscopy." 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 component damage or breakage" and "precaution: minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the report of a kinked catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed three kinks on the catheter body towards the juncture hub.The catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the returned sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: ARROW PI PICC 1L 4FRX55CM W/130CM HYDR NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 23597326
• Report Number: 9680794-2025-00965
• Device Sequence Number: 13381405
• Product Code: LJS
• UDI-Device Identifier: 00801902095565
• UDI-Public: (01)00801902095565(11)250311(17)270228(10)33F25A0049(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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 Catalogue Number: PR-35541-HPHNL
• Device Lot Number: 33F25A0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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
• Patient Sex: Unknown