MAUDE Adverse Event Report: BARD ACCESS SYSTEM, INC. POWERPORT; PORTACATH

Model Number REF 1808000

Device Problem Fracture (1260)

Patient Problem Blood Loss (2597)

Event Date 02/07/2017

Event Type  malfunction  

Event Description

Patient sent for interventional radiology fluoroscopy on (b)(6) 2017 for malfunctioning left sided port for several weeks with no blood return.Testing confirmed the catheter was fractured in the center of the catheter tubing.On (b)(6) 2017 - removal of powerport in interventional radiology.

• Brand Name: POWERPORT
• Type of Device: PORTACATH
• Manufacturer (Section D): BARD ACCESS SYSTEM, INC.; salt lake city UT 84116
• MDR Report Key: 6394662
• MDR Text Key: 69762119
• Report Number: MW5068374
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 1808000
• Device Catalogue Number: 1808000
• Device Lot Number: REXH1708
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 57 YR
• Patient Weight: 86