MAUDE Adverse Event Report: PALL CORPORATION PALL POSIDYNE® NEO FILTER; FILTER, INFUSION LINE

Model Number	NEO96
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two instances of the a cardiac filter to be leaking.Filter was removed from line in each instance.

• Brand Name: PALL POSIDYNE® NEO FILTER
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park drive; port washington NY 11050
• MDR Report Key: 16435225
• Report Number: 16435225
• Device Sequence Number: 19633088
• Product Code: FPB
• UDI-Device Identifier: 00636207300904
• UDI-Public: (01)00636207300904
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/30/2023
• Report Date (Section F): 01/30/2023

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: Health Professional
• Device Model Number: NEO96
• Device Catalogue Number: NEO96
• Device Lot Number: 22-564
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 6 KG
• Date Report Sent to FDA: 01/30/2023