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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7357-24
Device Problem Fluid Leak (1250)
Patient Problem No Information (3190)
Event Date 01/20/2021
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration sets - flow stop leaked iv fluid. There were no adverse events reported.
 
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Brand NameCADD
Type of DeviceSET, 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 Key11408701
MDR Text Key234615183
Report Number3012307300-2021-01731
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7357-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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