MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP MRI 9.6SI INT WOSP, ATT, SL; IMPLANTABLE PORT

Model Number	1809661
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the alleged fluid leak issue.The root cause could not be determined.The device as labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicates that model 1809661, implantable port, allegedly experienced a fluid leak.This information was received from a single source.This malfunction involved a female patient with no consequences.The patient's age and weight were not provided.

• Brand Name: POWERPORT ISP MRI 9.6SI INT WOSP, ATT, SL
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9963164
• Report Number: 3006260740-2020-01313
• Device Sequence Number: 2785105
• Product Code: LJT
• UDI-Device Identifier: 00801741027161
• UDI-Public: (01)00801741027161
• 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): 04/15/2020

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: 1809661
• Device Catalogue Number: 1809661
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1