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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problems Dyspnea (1816); Pain (1994)
Event Type  malfunction  
Event Description
Information was received indicating that during use of this smiths medical cadd extension sets, leaking at the filter was noticed. The patient reported experiencing pain and shortness of breath. No additional adverse effects were reported.
 
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Brand NameCADD EXTENSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12683658
MDR Text Key278090075
Report Number3012307300-2021-10166
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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