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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 21-7302-24
Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that while in use of a smiths medical cadd cassette reservoir, an under delivery of medical fluid was observed in the product.No adverse effects were reported.
 
Manufacturer Narrative
Three cadd cassette reservoir was returned for the evaluation of the reported under-delivery of medical fluids.Pictures were also attached, but no defects were detected in the pictures.A visual inspection was performed and no defects were detected.Then an accuracy testing was performed where the samples were connected to the cadd legacy pluss and a balance mettler toledo to accuracy test the sample according to procedure.No discrepancies were detected the accuracy test was successfully passed.No actions were performed as the complaint was not confirmed.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11300626
MDR Text Key231696002
Report Number3012307300-2021-01031
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/12/2021
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 No Information
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4013377
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/13/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received02/09/2021
Supplement Dates Manufacturer Received03/14/2021
Supplement Dates FDA Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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