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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD ADMINISTRATION SETS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7391-24
Device Problems Partial Blockage (1065); Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that the device under delivered the medication.A kink in the tubing was observed.No patient injury was reported.
 
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Brand Name
CADD ADMINISTRATION SETS WITH FLOW STOP
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15310763
MDR Text Key305268817
Report Number3012307300-2022-16491
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027512
UDI-Public10610586027512
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2022
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 Health Professional
Device Model Number21-7391-24
Device Catalogue Number21-7391-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/12/2022
Initial Date FDA Received08/29/2022
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
Patient Sequence Number1
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