MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, FLOW DIRECTED

Model Number IPN923529

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

As noted in the comments, there was a small hole in the side of the catheter that was outside the body.Contrast was injected through the catheter using a power injector.Power injector settings were confirmed appropriate for the catheter.No harm to the patient, as the defective part of the catheter did not enter the body.

• Brand Name: ARROW
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 16910439
• MDR Text Key: 314986919
• Report Number: 16910439
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN923529
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22G0068
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1460 DA
• Patient Sex: Female