MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SM TI P.C. PORT W/INT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602190
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the 602190 sm ti p.C.Port w/int was returned to the manufacturer.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 602190 sm ti p.C.Port w/int experienced having foreign material present in device.Of this event, the device was used on the patient with no reported injury.The patient was a (b)(6) male with no weight reported.The 602190 sm ti p.C.Port w/int was returned to the manufacturer and is pending investigation.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; however electronic photos were received and reviewed.Based on the photo review, the investigation is confirmed for unknown material in the blood.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 602190 port & catheter, implanted, subcutaneous, intravascular allegedly experienced having foreign material present in device.Of this event, the device was used on the patient with no reported injury.The patient was a 24-year-old male with no weight reported.

• Brand Name: SM TI P.C. PORT W/INT
• 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: 8529867
• Report Number: 2020394-2019-00494
• Device Sequence Number: 2384381
• Product Code: LJT
• UDI-Device Identifier: 00801741025549
• UDI-Public: (01)00801741025549
• 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,Followup
• Report Date (Section B): 07/24/2019

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: 0602190
• Device Catalogue Number: 0602190
• Device Lot Number: RETI0047
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1