MAUDE Adverse Event Report: POLYSITE PI IMPLANTABLE INFUSION PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	4018PI
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional called in and stated they had placed a port for a cancer patient, and noticed after a year that there is some leaking.They removed the port and replaced it.The patient condition was reported as fine post-procedure.
Additional Manufacturer Narrative
The potential lot affected is lot number 18050137.The review of the manufacturing batch record of the polysite 4018pi implantable port final product (lot 18050137) did not highlight any deviation that could be the root cause of the incident.Indeed, the sealing of the port-catheter-connection ring assembly is verified on 100% of the devices manufactured by injecting air at a pressure of 2.2 bar +/- 0.2 bar for 1 minute.Alteration of the catheter or connecting ring would most likely have led to a leakage and would have been detected.The leak test performed on the (b)(4) units manufactured is in accordance with the specifications.No deviation was detected.The device is in transit for returned to perouse medical.Perouse medical hasn't been informed of other incidents implying the batch 18050137 (potential lot).We asked more information about the incident (date implantation, date explantation, venous access routes, implantation and explantation reports, copy of x-ray pictures for implantation and observation of event, the consequences for the patient).We are waiting for the device in order to perform a technical investigation.

• Brand Name: POLYSITE PI IMPLANTABLE INFUSION PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer Contact: agnès jordan ; 4 rue saint-anne; ivry-le-temple, 60173 ; FR 60173
• MDR Report Key: 15548087
• Report Number: 3006942524-2022-02358
• Device Sequence Number: 1905240
• Product Code: LJT
• UDI-Device Identifier: 03661234017638
• UDI-Public: 03661234017638
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4018PI
• Device Lot Number: 18050137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown