• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Event Description
Spontaneous call from pt who reported that the other day, the pump alarmed for blockage. She stated that she could not find any kinks in the tubing so she decided to replace it. While replacing the tubing, the pump alarmed that cartridge needed to be changed she accidentally spilled some of her medication while she was replacing the cartridge. Lot numbers for the tubing and cartridge are unknown. Pt did not experience any clinical injuries during this event. Unknown if her doctor is aware. Did the reported product fault occur while in use with a patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available to be returned for investigation? yes; did we replace device? no; did the patient have backup device they were able to switch to? yes; but patient did not need to use it; if yes, was the patient able to successfully continue their infusion? yes; what is outcome? resolved. Reported to (b)(6) by pt/caregiver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINF SET CLEO 31" 9MM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11607817
MDR Text Key243750157
Report NumberMW5100506
Device Sequence Number2
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 03/01/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
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
Is This a Reprocessed and Reused Single-Use Device? No

-
-