MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD INFUSE-A-PORT 6FR

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/10/2016

Event Type  Injury  

Event Description

A (b)(6) hemophiliac had a port which was not able to be accessed on (b)(6) 2016.Port originally placed on (b)(6) 2014.Chest x-ray obtained on (b)(6) 2016 showed the catheter portion of the right-sided infus-a-port had dislodged and migrated into the left pulmonary artery.Pt taken to the cath lab by interventional cardiology to remove the catheter.General surgery then removed the fractured port and implanted a replacement 8fr port as pt was still in need of continued access.Pt recovered well and was discharged on (b)(6) 2016.

• Brand Name: BARD INFUSE-A-PORT 6FR
• Type of Device: PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n 5600 w; sale lake city UT 84116
• MDR Report Key: 6256380
• MDR Text Key: 65078408
• Report Number: 6256380
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR
• Patient Weight: 48