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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 2101928
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Spontaneous email from (b)(6), nurse from doctor's office, who reported: "per patient her remodulin sites have only been lasting 2 weeks since she had to switch to the cleo insertion due to silhouette being discontinued. " no other information provided. Unk if there is product problem with the pt's cleo tubing. Reported (b)(6) by health professional.
 
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Brand NameINF SET CLEO 31" 9MM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11715803
MDR Text Key247217542
Report NumberMW5100943
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 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number2101928
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
Is This a Reprocessed and Reused Single-Use Device?

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