MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM); WIRE, GUIDE, CATHETER

Catalog Number	ASK-04120-HF3
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one s-l catheter for evaluation.Upon inspection, it was determined that the returned catheter does not correspond to the catheter associated with the reported finished good.The catheter in the finished good has suture wings along the hub, and the returned catheter did not match the product drawing.Visual examination of the returned sample revealed signs of use along the extrusion and within the tip.Microscopic analysis confirmed damage to the catheter tip; however, there is no evidence of a portion of the catheter separating from the body.Multiple attempts were made to contact the customer to clarify the discrepancies between the report and the returned sample.No response has been received.A device history record review was performed and no relevant findings were identified.The customer report of a spliced catheter could not be confirmed through complaint investigation of the returned sample.The customer returned one s-l catheter for evaluation with evidence of a deformed tip.Upon inspection, it was determined that the returned catheter design (no suture wings on catheter hub) does not correspond to the catheter design associated with the reported finished good (suture wings on catheter hub).Visual examination revealed signs of use along the extrusion and within the tip.A device history record review was performed on the reported batch, and no relevant findings were identified.Multiple attempts were made to contact the customer to clarify the discrepancies between the report and the returned sample, however, no response has been received.Based on the discrepancy between the customer report and sample received, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "a pa for our cardiothoracic surgery team just placed it.It broke or spliced as the pa said when she attempted to advance it.I believe this is the same issue that's been occurring." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number includes: 9680794-2025-00729.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22913089
• Report Number: 9680794-2025-00728
• Device Sequence Number: 9055103
• Product Code: DQX
• UDI-Device Identifier: 10801902200447
• UDI-Public: (01)10801902200447(11)250227(17)260930(10)33S24A1516(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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: 09/30/2026
• Device Catalogue Number: ASK-04120-HF3
• Device Lot Number: 33S24A1516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.
• Patient Sex: Unknown