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

Device Problems Disconnection (1171); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 03/16/2019

Event Type  malfunction  

Event Description

Tpn filter found disconnected from central venous line, laying in patients' bed.Filter contaminated and unable to be used.

• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park drive; port washington NY 11050
• MDR Report Key: 9025641
• MDR Text Key: 158134668
• Report Number: 9025641
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 03/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2019
• Type of Device Usage: N
• Patient Sequence Number: 1