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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
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
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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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15250522
Report Number3012307300-2022-07387
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 Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/05/2022
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

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