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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
Catalog Number 21-7105-24
Medical Device Problem Codes Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/24/2019
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that there was a delivery issue that occurred three times with a fentanyl infusion.The allegation of malfunction is on the cadd cassette reservoir.The patient reported that two units have a "faulty minute av bubbles" in the line despite flushing.The issues reported were air bubbles and downstream occlusion.There was no report of patient injury or medical intervention as a result of this event.
 
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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 Key9263177
Report Number3012307300-2019-05188
Device Sequence Number1879046
Product Code FPA
UDI-Device Identifier10610586022715
UDI-Public10610586022715
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 10/31/2019
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 Date10/18/2023
Device Catalogue Number21-7105-24
Device Lot Number3713021
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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