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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD SET, ADMINISTRATION, INTRAVASCULAR

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NULL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem Headache (1880)
Event Type  Injury  
Event Description
Information was received indicating that while in use of a smiths medical cadd tubing, the patient stated that she was having headache and then noticed that her tubing was leaking where the central line is. It was reported that the patient has been on medication for at least 5 years and confirms that is not the central line itself or the iv connector and it certainly is the tubing. The patient was advised to change tubing. No further adverse effects were reported.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key11914213
MDR Text Key253548941
Report Number3012307300-2021-05338
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received06/03/2021
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 Initial

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