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

Device Problems Crack (1135); Disconnection (1171)

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

Event Date 02/09/2020

Event Type  malfunction  

Event Description

Total parenteral nutrition filter cracked and disconnected.

• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 9744609
• MDR Text Key: 180611481
• Report Number: 9744609
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1