MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP 9.6 FR. SILILCONE SINGLE LUMEN CATHETER; IMPLANTABLE PORT

Model Number	1859660
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For six of the seven reported events, the devices were returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes seven malfunction events.A review of the events indicated that model 1859660 implantable port experienced a component missing.These reports were received from various sources.All seven reported events did not involve a patient.Patient age, weight, and gender were not provided for any of the events.
Additional Manufacturer Narrative
The lot number for the reported seven malfunctions was provided and a lot history review was performed.For the seven reported malfunctions, five devices were returned.Five out of seven of the investigations were confirmed for missing component and two were inconclusive for missing component.The definitive root cause for all seven investigations is unknown.The device was used for single use.
Event or Problem Description
This report summarizes seven malfunction events.A review of the events indicated that model 1859660 implantable port experienced a component missing.These reports were received from various sources.All seven reported events did not involve a patient.Patient age, weight, and gender were not provided for any of the events.

• Brand Name: POWERPORT MRI ISP 9.6 FR. SILILCONE SINGLE LUMEN CATHETER
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8531614
• Report Number: 3006260740-2019-01037
• Device Sequence Number: 1839761
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222
• 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): 07/23/2019

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: 1859660
• Device Catalogue Number: 1859660
• Device Lot Number: RECU0481
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1