MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT TI LOW PROFILE, 6 FR CHRONOFLEX, MI, W/ SUTURE PLUGS, ATTACH.; IMPLANTABLE PORT

Model Number	1716070
Medical Device Problem Codes	Suction Problem (2170); Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the two complaints, 1 lot number was provide and lot history reviews were performed.Of the 2 reported malfunctions, no devices were returned for evaluation.Therefore, the investigation is inconclusive.A root cause has not been determined.The devices were labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 1716070.Implantable port allegedly experienced suction issue, failure to infuse.These reports were received from various sources.Both events did involve patients with no reported patient injury.One patient is female; however, the other patients¿ weight, gender and age were not reported.

• Brand Name: POWERPORT TI LOW PROFILE, 6 FR CHRONOFLEX, MI, W/ SUTURE PLUGS, ATTACH.
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9599196
• Report Number: 3006260740-2020-00180
• Device Sequence Number: 3244182
• Product Code: LJT
• UDI-Device Identifier: 00801741026768
• UDI-Public: (01)00801741026768
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1716070
• Device Catalogue Number: 1716070
• Device Lot Number: UNKNOWN, RECR1862
• 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