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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 21-7383-24
Medical Device Problem Code Device Alarm System (1012)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that immediately on use, the smiths medical cadd administration set had air bubbles inside tube alarm.No adverse effects were reported.
 
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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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 Key11332681
Report Number3012307300-2021-01270
Device Sequence Number16998114
Product Code FPA
UDI-Device Identifier10610586027475
UDI-Public10610586027475
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/28/2021
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
Operator of Device Lay User/Patient
Device Expiration Date05/19/2025
Device Model Number21-7383-24
Device Catalogue Number21-7383-24
Device Lot Number3971522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/19/2021
Supplement Date Received by Manufacturer05/01/2021
Initial Report FDA Received Date02/16/2021
Supplement Report FDA Received Date05/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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