MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Model Number CDC-42802XP1A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

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

Event Date 01/14/2020

Event Type  malfunction  

Event Description

During placement of a left subclavian central line by a surgeon, when the guide wire was pulled out after placing the catheter, it was difficult to remove. When removed, the wire was found to be frayed/unraveled. A new guide wire was used to ensure correct placement of the catheter and a chest x-ray was taken to look for any part of the guide wire that may have been retained. Per the radiologist, "no metallic radiopaque foreign body identified". Packaging and wire given to manager and sequestered.

• Brand Name: ARROW
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9877349
• MDR Text Key: 184847542
• Report Number: 9877349
• 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: 02/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CDC-42802XP1A
• Device Lot Number: 23F19J008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2020
• Event Location: No Information
• Date Report to Manufacturer: 03/25/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage