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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 Difficult to Remove (1528)
Patient Problem Skin Irritation (2076)
Event Type  Injury  
Event Description
Pt report great difficulty in removing cleo when it's time to change the tubing.It often gets stuck and by the time the pt gets it off, his site will be very irritated.No other info available or reported.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
INF SET CLEO 42" 9MM
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key9877727
MDR Text Key185051296
Report NumberMW5093912
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 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/24/2020
Patient Sequence Number1
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