MAUDE Adverse Event Report: COVIDIEN ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC)

Model Number 43304

Device Problems Hole In Material (1293); Leak/Splash (1354); Device Displays Incorrect Message (2591)

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

Event Date 12/17/2017

Event Type  malfunction  

Event Description

Pump alarmed high pressure.Nurse went to flush / aspirate to assess patency and the fluid leaked under the dressing.This was on a pt that needed to go to surgery in the morning and needed to get another picc inserted.When assessing the line afterwards there was a small hole in the part under the dressing but not inserted into the pt.

• Brand Name: ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC)
• Type of Device: ARGYLE PERIPHERAL INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7137453
• MDR Text Key: 95506760
• Report Number: MW5074137
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43304
• Device Lot Number: 1716600236
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 MO