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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD INC. INF-SET CLEO 42" 9MM SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL, ASD INC. INF-SET CLEO 42" 9MM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Failure to Deliver (2338); Connection Problem (2900)
Patient Problems Headache (1880); Nausea (1970); Pain (1994)
Event Type  Injury  
Event Description
Patient will increasing every month now due to side effects. Md aware. Nausea, diarrhea, foot pain, headaches. Patient also report issue with cleo last week where it did not connect to site correctly and pump alarmed and delivery was stopped for 20 or 30 min. Patient was unsure if she was supposed to change cartridge in tha situation, so she changed cartridge and tubing. Reminded patient about on call rph. No other information available. Reported to (b)(6) by pt/caregiver.
 
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Brand NameINF-SET CLEO 42" 9MM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL, ASD INC.
MDR Report Key12107719
MDR Text Key260074021
Report NumberMW5102253
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 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
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
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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