MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-34052-HPHNM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "45cm wires had distinctive kinks where the straight wire meets the soft tip.".This was found prior to use.There was no patient involvement.Associated mdr numbers include: 9680794-2025-00646 and 9680794-2025-00632.
Event or Problem Description
It was reported "45cm wires had distinctive kinks where the straight wire meets the soft tip." this was found prior to use.There was no patient involvement.Associated mdr numbers include: 9680794-2025-00646 and 3006425876-2025-00750.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and the product lidstock for evaluation.The guide wire advancer tubing was not returned.No obvious signs of use were observed.No defects or anomalies were observed on the guide wire.The length of the guide wire measured 45.0 cm, which is within the specification limits of 43.75-46.25 cm per guide wire product drawing.The outer diameter of the guide wire measured 0.018", which is within the specification limits of 0.0160"-0.0185" per guide wire product drawing.The guide wire was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into introducer needle." the guide wire was advanced through a lab inventory 21ga introducer needle.The guide wire passed through with little to no resistance.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user , "do not use if package is damaged." the report that the guide wire was kinked was not confirmed through complaint investigation of the returned sample.No defects or anomalies were observed on the returned guide wire.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and sample received, no problem was found.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO 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: 22629219
• Report Number: 9680794-2025-00646
• Device Sequence Number: 8154892
• Product Code: LJS
• UDI-Device Identifier: 00801902100979
• UDI-Public: (01)00801902100979(11)240216(17)251130(10)33F24A0423(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: PR-34052-HPHNM
• Device Lot Number: 33F24A0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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