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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 Name
CADD EX SET
Type of Device
SET, 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
1 Patient was 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 No Information
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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