MAUDE Adverse Event Report: BARD ACCESS SYSTEMS XPORT ISP MRI 6FR CFLEX W/ BASIC KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 0607500 implanted port experienced a fluid leak.The port was observed to have a longitudinal split in the catheter.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.

• Brand Name: XPORT ISP MRI 6FR CFLEX W/ BASIC KIT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8529506
• Report Number: 3006260740-2019-01004
• Device Sequence Number: 11230454
• Product Code: LJT
• UDI-Device Identifier: 00801741026140
• UDI-Public: (01)00801741026140
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0607500
• Device Catalogue Number: 0607500
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1