MAUDE Adverse Event Report: SET EXT 60IN W/ .2 MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4339721

Device Problem Disconnection (1171)

Patient Problem Diarrhea (1811)

Event Date 02/02/2020

Event Type  malfunction  

Event Description

Inbound, pt complained of stomach flu symptoms and diarrhea, also stated the tubing disconnected from the cassette and this has happened twice; the lot numbers is 4339721.No further details provided.(b)(6) medical - surgical.

• Brand Name: SET EXT 60IN W/ .2 MICRON FILTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 9729144
• MDR Text Key: 180707720
• Report Number: MW5093095
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 02/07/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4339721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR