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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7062-24
Medical Device Problem Codes Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/21/2019
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that during use, it was noted that a smiths medical cadd extension set snapped apart and the patient noticed that his backpack was wet.No patient consequences were reported.No adverse effects were reported.
 
Additional Manufacturer Narrative
A1-4: patient demographics provided.Patient weight and age marked as unknown.
 
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Brand Name
CADD EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9519980
Report Number3012307300-2019-06979
Device Sequence Number10839399
Product Code FPA
UDI-Device Identifier10610586020452
UDI-Public10610586020452
Combination Product (Y/N)N
Initial Reporter CountryFI
PMA/510(K) Number
K942046
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/04/2020
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 Lay User/Patient
Device Expiration Date11/13/2023
Device Model Number21-7062-24
Device Catalogue Number21-7062-24
Device Lot Number3733180
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/29/2019
Supplement Date Received by Manufacturer01/08/2020
Initial Report FDA Received Date12/26/2019
Supplement Report FDA Received Date02/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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