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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 21-7363-24
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Information was received indicating that a smiths medical tubing was implicated in causing purging speed differences. Additionally, more then 10ml of tubing was needed instead of 8ml. There were no reported adverse events.
 
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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)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11120653
MDR Text Key225256340
Report Number3012307300-2021-00065
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7363-24
Device Lot Number4019453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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