MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ADULT MRI W/6FR CHX PEEL; IMPLANTABLE PORT

Model Number	0607173
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the two lot numbers for the devices were provided, a manufacturing review will be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
This report summarizes two malfunction events.A review of the events indicated that model 0607173 implantable port was allegedly unable to be aspirated.These reports were received from one source.One patient was involved for the two events with no reported patient injury.The patient was (b)(6) years of age, (b)(6) and female.

• Brand Name: ADULT MRI W/6FR CHX PEEL
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532287
• Report Number: 3006260740-2019-01048
• Device Sequence Number: 1612391
• Product Code: LJT
• UDI-Device Identifier: 00801741026096
• UDI-Public: (01)00801741026096
• 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): 04/19/2019

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: 0607173
• Device Catalogue Number: 0607173
• Device Lot Number: REXC0705, RESK0056
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1