POWER PICC IV LINE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-22 for POWER PICC IV LINE * manufactured by Bard Access Systems.

Event Text Entries

[369799] Picc line clotted, retavase was used to open the line. The iv line was successfully open. Facility's advanced practice nurse will be evaluating these occurrences.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 590912
• MDR Report Key: 590912
• Date Received: 2005-03-22
• Date of Report: 2005-03-22
• Date of Event: 2005-03-05
• Report Date: 2005-03-22
• Date Reported to FDA: 2005-03-22
• Date Added to Maude: 2005-04-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: POWER PICC IV LINE
• Generic Name: PICC IV LINE
• Product Code: DQO
• Date Received: 2005-03-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 580768
• Manufacturer: BARD ACCESS SYSTEMS
• Manufacturer Address: 5425 WEST AMELIA EARHART DRIVE SALT LAKE CITY UT 84116 US

Device Sequence Number: 2

• Brand Name: CLC 2000
• Generic Name: CATHETER CONNECTOR
• Product Code: GCD
• Date Received: 2005-03-22
• Model Number: CLC 2000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 580769
• Manufacturer: ICU MEDICAL INC.
• Manufacturer Address: 951 CALLE AMANECER SAN CLEMENTE CA 92673 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-22