MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Model Number	IPN925140
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to insertion of central line dilator that the tip looked different with a dried rust color.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 23411935
• Report Number: 23411935
• Device Sequence Number: 18399155
• Product Code: DYB
• UDI-Device Identifier: 10801902210996
• UDI-Public: (01)10801902210996
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2025
• Report Date (Section F): 09/26/2025

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 Model Number: IPN925140
• Device Catalogue Number: CDC-21242-XCN1A
• Device Lot Number: 33F25C0217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Date Report Sent to FDA: 09/26/2025