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U.S. Department of Health and Human Services

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

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SET EXT 60IN W/ .2 MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameSET EXT 60IN W/ .2 MICRON FILTER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key9729144
MDR Text Key180707720
Report NumberMW5093095
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4339721
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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