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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET

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ST PAUL CADD EXTENSION SET Back to Search Results
Model Number 21-7106-24
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Respiratory Distress (2045)
Event Type  Injury  
Event Description
Information was received indicating that the patient was admitted to the hospital for shortness of breath and line issues while using a smiths medical cadd extension set. The shortness of breath might have been caused by the line issues and not getting medication properly.
 
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Brand NameCADD EXTENSION SET
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
minneapolis, MN 55442
MDR Report Key11358567
MDR Text Key232832360
Report Number3012307300-2021-01417
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/22/2021 Patient Sequence Number: 1
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