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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 Problem Product Quality Problem (1506)
Patient Problem Malaise (2359)
Event Date 11/06/2021
Event Type  Injury  
Event Description
Solicited call to patient's mother who reported that patient's site does not last any longer than 2-4 weeks. She spoke to the cvs field nurse about them and was advised that the patient might get sites that last longer if she doesn't use the cleo system. Her last site change was on (b)(6) 2021 and she wasn't feel well afterwards. Her doctor advised her to lower her pump rate for remodulin from maintenance rate of (b)(4) to (b)(4) and then to go back up when she is feeling better. She is feeling better now. No other information provided. Reported to cvs/caremark 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 Key12814525
MDR Text Key280935918
Report NumberMW5105320
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes

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