MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPORT TI LP 8F GR INT; IMPLANTABLE PORT

Model Number	1718501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection.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 1718501 implanted port allegedly experienced a break.This information was received from one source.This malfunction involved one patient with no consequences.The (b)(6) year old female patient was (b)(6).

• Brand Name: PPORT TI LP 8F GR INT
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9599194
• Report Number: 3006260740-2020-00175
• Device Sequence Number: 3461224
• Product Code: LJT
• UDI-Device Identifier: 00801741026829
• UDI-Public: (01)00801741026829
• 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): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1718501
• Device Catalogue Number: 1718501
• Device Lot Number: REDT4444
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1