MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35052-HPHNM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "when the product was opened for the picc procedure in the angiography room, it was found that the wire is bent.It was replaced with the new product." this was found prior to use.There was no patient involvement.
Event or Problem Description
It was reported "when the product was opened for the picc procedure in the angiography room, it was found that the wire is bent.It was replaced with the new product." this was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened picc kit including multiple components for analysis.Signs of use in the form of biological material were observed on the inside of the tray.It is assumed that this biological material came from the customer handling with bloody gloves.The catheter body was also observed to be severed at an angle at the 39/11cm marking.The severed end was not returned.Visual analysis confirmed that the guide wire was kinked at the coiled section.It was also noted that the guide wire was returned partially deployed outside of the tubing.During normal assembly, the proximal end of the guide wire is meant to partially exit the wire snubber.This was not the case for the returned sample.The guide wire was reassembled inside the tubing.The location of the kink is on the exposed section of the guide wire.Microscopic examination confirmed the kinking and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 17mm from the distal weld.The guide wire total length measured 45cm, which is within the specification limits of 43.75mm-46.25cm per the guide wire product drawing.The guide wire outer diameter measured 0.0175", which is within the specification limits of 0.0160"-0.0185" per the guide wire product drawing.The guide wire tubing measured 6 1/2", which is within the specification limits of 6 1/4"-6 3/4" per the guide wire assembly product drawing.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the 45cm guide wire was kinked on the coiled section.Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.It was determined that the root cause is likely manufacturing related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI PICC 2L 5FRX50CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 22018596
• Report Number: 9680794-2025-00424
• Device Sequence Number: 9484316
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)241208(17)260331(10)33F24L1154(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 03/31/2026
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F24L1154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2024
• 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