MAUDE Adverse Event Report: PALL CORPORATION PALL SUPOR® 1.2 FILTER; FILTER, INFUSION LINE

Model Number	AEF2NT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Filter keeps backing up in the iv infusion.

• Brand Name: PALL SUPOR® 1.2 FILTER
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 9750228
• Report Number: 9750228
• Device Sequence Number: 19476650
• Product Code: FPB
• UDI-Device Identifier: 00636207315434
• UDI-Public: (01)00636207315434
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/08/2020
• Report Date (Section F): 01/09/2020

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: AEF2NT
• Device Catalogue Number: AEF2NT
• Device Lot Number: 13384809
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/09/2020