MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ENDURANCE DWELL PERIPHERAL IV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number IPN037844

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  malfunction  

Event Description

Vascular nurse was preparing to place device when assessed catheter prior to placement, noted guide wire would not deploy.Did not attempt to use on patient.This facility had the same type of malfunction with this manufacturer's device approximately one week ago.Both products have been returned.The manufacturer has been notified.

• Brand Name: ARROW ENDURANCE DWELL PERIPHERAL IV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 8435593
• MDR Text Key: 139298340
• Report Number: 8435593
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN037844
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F18H0451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1