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

Model Number AEF2NT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

Filter keeps backing up in the iv infusion.

• Brand Name: PALL SUPOR® 1.2 FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 9750228
• MDR Text Key: 180749145
• Report Number: 9750228
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 00636207315434
• UDI-Public: (01)00636207315434
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2020,01/08/2020

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
• Device Operator: No Information
• Device Model Number: AEF2NT
• Device Catalogue Number: AEF2NT
• Device Lot Number: 13384809
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1