MAUDE Adverse Event Report: PALL LIFE SCIENCES PALL POSIDYNE ELD FILTER; NONE

Lot Number 412611

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/30/2014

Event Type  malfunction  

Event Description

Leakage from pall posidyne eld during an infusion of taxol.

• Brand Name: PALL POSIDYNE ELD FILTER
• Type of Device: NONE
• Manufacturer (Section D): PALL LIFE SCIENCES
• MDR Report Key: 4387018
• MDR Text Key: 5365097
• Report Number: MW5039933
• Device Sequence Number: 1
• Product Code: FPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2019
• Device Lot Number: 412611
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: TAXOL
• Patient Outcome(s): Other