MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4IN; WIRE GUIDE CATHETER

Catalog Number	RA-04020
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the full udi number is not available as complainant did not report a valid lot number.
Event or Problem Description
It was reported "anaethetist inserting arterial catheter had 2 failed attempts with no evidence of flash back seen.On removal strong bright blood flow indicating was in the artery on both occasions".A new kit was used to resolve the issue.The patient is fine and had no harm or injury.The associated emdr report numbers are 9680794-2025-00142.
Event or Problem Description
It was reported "anaethetist inserting arterial catheter had 2 failed attempts with no evidence of flash back seen.On removal strong bright blood flow indicating was in the artery on both occasions".A new kit was used to resolve the issue.The patient is fine and had no harm or injury.The associated emdr report numbers are 9680794-2025-00143 and 9680794-2025-00142.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one arterial catheterization device and the product lidstock for analysis.Signs of use in the form of biological material were observed on and within the device.Visual analysis did not reveal any obvious defects or anomalies with the returned device.Simulated use of the returned device was performed per the instructions for use (ifu) statement, "remove guard.Trial advance and retract guidewire through needle using guidewire handle to ensure proper function." the black handle on the guide wire was advanced through the track of the chamber.No resistance was experienced between the guide wire and chamber.A blockage was observed within the needle cannula 24 mm from the needle tip.The blockage was unable to be removed.Manufacturing was contacted as part of this complaint investigation.They confirmed that this is a verified teleflex issue.The manufacturing dates for the lot numbers of the catheterization device occurred prior to capa implementation (07-oct-2024).A device history record review was performed, and there was one potential finding.A non-conformance was initiated for 14p23f0165 in regard to stains on cannulas.The failure mode of this complaint is not the same as/relevant to the non-conformance identified.The reported event was confirmed through complaint investigation of the returned sample.Functional analysis a complete blockage within the needle cannula.A capa was previously implemented to address this issue.The capa investigation determined that the root cause is manufacturing related.The relevant lots within the reported kit were manufactured (october 2023-december 2023) prior to the implementation of the corrective action (october 2024).Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4IN
• Common Device Name: WIRE GUIDE 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: 21344543
• Report Number: 9680794-2025-00143
• Device Sequence Number: 7853733
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730(11)231213(17)281130(10)14F23M0048(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: RA-04020
• Device Lot Number: 14F23M0048
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown