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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7052-24
Device Problems Partial Blockage (1065); Obstruction of Flow (2423)
Patient Problem No Information (3190)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Information was received indicating that a smiths medical pump was alarming with occlusion. This issue does not happen with every extension line but it does happen with one specifically. There were no reported adverse events.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
glossop road
minneapolis, MN 55442
MDR Report Key10931424
MDR Text Key219116707
Report Number3012307300-2020-11980
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7052-24
Device Lot Number4016614
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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