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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 21-7349-24
Device Problems Complete Blockage (1094); Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical tubing was not flowing. The pump was working fine but no fluid was drained from the bag. There were no reported adverse events. The tubing was changed out and everything worked fine.
 
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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 Key11120606
MDR Text Key225254433
Report Number3012307300-2021-00098
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2021
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 Number21-7349-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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