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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7322-24
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/03/2020
Event Type  malfunction  
Event Description
It was reported that the cadd administration ser was under delivering.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Additional information: a1.Five photos were received of the cadd cassette reservoir were received.It can be observed that the arm and spring were removed; the other picture showed a top view of the housing with the arm and the spring activating the ffp system.No testing could be performed because no samples were provided to perform a thorough investigation.No cause of issue has been determined since the reported failure mode was not confirmed due to the fact that no samples were received to perform a thorough investigation.
 
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Brand Name
CADD ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9639858
MDR Text Key177431054
Report Number3012307300-2020-00827
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586029646
UDI-Public10610586029646
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 03/10/2020
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
Device Operator Lay User/Patient
Device Model Number21-7322-24
Device Catalogue Number21-7322-24
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2020
Initial Date FDA Received01/28/2020
Supplement Dates Manufacturer Received02/13/2020
Supplement Dates FDA Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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