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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADDADMINISTRATION SETS WITH FLOW STOP FREE-FLOW P SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADDADMINISTRATION SETS WITH FLOW STOP FREE-FLOW P SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7322-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
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Brand NameCADDADMINISTRATION SETS WITH FLOW STOP FREE-FLOW P
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
suite 10
minneapolis, MN 55442
MDR Report Key15234093
Report Number3012307300-2022-15422
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586029646
UDI-Public10610586029646
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7322-24
Device Catalogue Number21-7322-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/09/2022
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

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