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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD; SET, ADMINISTRATION, INTRAVASCULAR
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CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7339-24
Medical Device Problem Codes Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional contact: (b)(6).
 
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set was noted to be under delivering.No adverse effects were reported.
 
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Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12667076
Report Number3012307300-2021-10114
Device Sequence Number11802695
Product Code FPA
UDI-Device Identifier10610586027307
UDI-Public10610586027307
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/20/2021
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 Health Professional
Device Expiration Date03/19/2025
Device Model Number21-7339-24
Device Catalogue Number21-7339-24
Device Lot Number3955204
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2021
Initial Report FDA Received Date10/20/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured04/06/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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