MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERLINE POLYURETHANE; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number 0700615

Device Problems Air Leak (1008); Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/12/2018

Event Type  malfunction  

Event Description

Patient returned to the hospital for removal of a bard purple powerline 6 french double lumen catheter.Patient had been discharged two days prior with broviac.On the day of return mom had difficulty flushing the red lumen and when drawing back air bubbles were seen.A visible area of leakage was noted (on the red hub right where the tubing is attached)so the device was clamped and the hematology team was contacted.The patient went to or for removal for a line which had been placed approximately two months ago.The child has had three central lines in the last six months.They were all the same size.

• Brand Name: POWERLINE POLYURETHANE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7243723
• MDR Text Key: 99128063
• Report Number: 7243723
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 0700615
• Device Catalogue Number: 0700615
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2018
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other