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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
Model Number 21723124
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Patient advised about 2-3 month ago her tubing showed dark blue discoloration inside her tubing and so she did a new mix/tubing and it cleared, and now sometime this week she did a mix and about 2 days later her cleo tubing in the middle was dark blue/black in the middle of her tubing, and it is inside the tubing and so she did a new mix yesterday and then noticed this morning that there is that discoloration again but it is closer to her site.Per patient no side effects, no site issues.When asking patient if she thinks it is blood patient wasn't sure.Reporting this as both product complaint on tubing and adverse event on remodulin since it may be blood.Patient did not have lot number for the tubing.I advised patient to keep her tubing in case we need.(b)(6) field nurse requested to reassess patient.No further information is known.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
INF SET CLEO 31" 9MM
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key13343606
MDR Text Key284468420
Report NumberMW5106936
Device Sequence Number3
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 01/20/2022
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number21723124
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2022
Patient Sequence Number1
Patient SexFemale
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