MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT, TI, ISP, 6 FR CHRONOFLEX, INTER. W/O SUTURE PLUG; IMPLANTABLE PORT

Model Number	1706061
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided; therefore, a lot history review is currently being performed.The sample was 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 device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 1706061 implantable port allegedly experienced obstruction of flow.This information was received from one source.One patient was involved with no patient consequences.The patient was a (b)(6) female.Weight information was not provided.

• Brand Name: POWERPORT, TI, ISP, 6 FR CHRONOFLEX, INTER. W/O SUTURE PLUG
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9960519
• Report Number: 3006260740-2020-01295
• Device Sequence Number: 2377791
• Product Code: LJT
• UDI-Device Identifier: 00801741026553
• UDI-Public: (01)00801741026553
• 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): 04/14/2020

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: 1706061
• Device Catalogue Number: 1706061
• Device Lot Number: REDS1460
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1