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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 2120
Medical Device Problem Codes Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/01/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set did not infuse epidural medication.No adverse effects were reported.
 
Event or Problem Description
Oracle ro 1072182: high flow.Update oracle ro 1075297: high flow.Evaluation completed in h 10.
 
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Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10241070
Report Number3012307300-2020-06703
Device Sequence Number11766274
Product Code FRN
UDI-Device Identifier10610586027307
UDI-Public10610586027307
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K111275
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 08/21/2020
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
Operator of Device No Information
Device Expiration Date04/22/2025
Device Model Number2120
Device Catalogue Number21-2120-0102-51
Device Lot Number3976365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/09/2020
Supplement Date Received by Manufacturer06/09/2020
Initial Report FDA Received Date07/07/2020
Supplement Report FDA Received Date08/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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