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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Operator of device is unknown.No information has been provided to date.
 
Event Description
It was reported that the cassette was delivering medication too quickly.
 
Manufacturer Narrative
Other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.
 
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Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16574538
MDR Text Key311608376
Report Number3012307300-2023-02715
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 User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/27/2023
Initial Date FDA Received03/20/2023
Supplement Dates Manufacturer Received06/26/2023
Supplement Dates FDA Received06/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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