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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
Device Problem Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
Per pt, a large majority of the inf set cleos that she received from us are not disconnecting from her sq site when she tries to change the tubing and therefore, she had to change her sq site 4 times in the month of december alone in order to change the tubing. No adverse events experienced due to defective product. Unknown if patient has defective product on hand for return. Reported to (b)(6) by pt/caregiver.
 
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Brand NameINF SET CLEO 31" 9MM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11462695
MDR Text Key239737782
Report NumberMW5099935
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/04/2021
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
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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