MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS KIT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 2652034

Device Problems Occlusion Within Device (1423); No Flow (2991)

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

Event Date 04/04/2018

Event Type  malfunction  

Event Description

Power loc port with not flush - there is a blockage somewhere in the tubing or needle.This has happened twice in the oncology department - same lot number.

• Brand Name: PORT ACCESS KIT
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7442835
• MDR Text Key: 105918482
• Report Number: 7442835
• Device Sequence Number: 1
• Product Code: LJT
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2652034
• Device Catalogue Number: 2652034
• Device Lot Number: REBY0450
• Other Device ID Number: NEEDLE LOT: ASBXS0038
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.