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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7343-24
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 01/02/2021
Event Type  malfunction  
Event Description
Information was received indicating that while in use of a smiths medical cadd administration set, the cassette could not stay in the right place and it came off from the bottom of the pump. Subsequently, new administration set was used and worked correctly. It was also reported that the patient, who is a child, and the parents were scared about the situation. No further adverse effects were reported.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11301925
MDR Text Key230982685
Report Number3012307300-2021-01053
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7343-24
Device Catalogue Number21-7343-24
Device Lot Number3984193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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