MAUDE Adverse Event Report: CENTURION CENTURION; TRIPLE LUMEN CENTRAL LINE

Model Number 7FRX 16 CM

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 11/30/2014

Event Type  Injury  

Event Description

Centurion triple lumen central line 7frx 16cm lot 2014102050 exp 04/16 was placed on (b)(6) 2014 and after brown port was accessed afterwards, noted leaking diprivan which was infusing and when diprivan was disconnected and brown port flushed- noted hole just past start of catheter.Ivf's disconnected and peripheral site obtained and central line clamped distal to hole and charge nurse and radiologist and resident notified.Central line was exchanged over the wire.Catheter will be made available to manufacturer.

• Brand Name: CENTURION
• Type of Device: TRIPLE LUMEN CENTRAL LINE
• Manufacturer (Section D): CENTURION
• MDR Report Key: 4305781
• MDR Text Key: 5057694
• Report Number: MW5039412
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 7FRX 16 CM
• Device Lot Number: 2014102050
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 89