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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD EX SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Infusion or Flow Problem (2964)
Patient Problem Dyspnea (1816)
Event Type  Injury  
Event Description
Inbound call from (b)(6) with medical doctor office: patient has been admitted to (b)(6) hospital for shortness of breath and line issues. Shortness of breath may have been caused by the line issue and not getting the medication properly. No additional information provided. Reported to (b)(6) by: health professional.
 
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Brand NameCADD EX SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11116907
MDR Text Key225358948
Report NumberMW5098668
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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