MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. M.R.I.¿ LOW-PROFILE IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number M.R.I.¿ LOW-PROFILE

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 01/28/2015

Event Type  malfunction  

Event Description

Implantable port was removed from patient due to leak.Once removed, the surgeon noted that this port has a hole on the back side allowing fluid to leak.

• Brand Name: M.R.I.¿ LOW-PROFILE IMPLANTABLE PORT
• 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: 4538913
• MDR Text Key: 5513237
• Report Number: 4538913
• Device Sequence Number: 1
• Product Code: LKG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: M.R.I.¿ LOW-PROFILE
• Device Catalogue Number: 3465
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2015
• Patient Sequence Number: 1
• Patient Age: 4 YR