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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cassette was leaking fluorouracil.This was discovered while filling the cassette.The drug began to fill up the plastic casing outside of the inner bag.The cassette was able to be filled to approximately 94 ml before it started leaking.There were no reported adverse events.
 
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Brand Name
CADD CASSETTE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11301048
MDR Text Key230954719
Report Number3012307300-2021-01035
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7302-24
Device Lot Number4046845
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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