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

Model Number ELD96LL

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 07/09/2020

Event Type  malfunction  

Event Description

Fluid leaking from picc cap area for lasix infusion, cap intact.However luer lock end on the micron filter appeared cracked with obvious medication leaking.

• Brand Name: PALL POSIDYNE ELD FILTER
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 10301163
• MDR Text Key: 199672752
• Report Number: 10301163
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ELD96LL
• Device Catalogue Number: ELD96LL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1