• 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. CLEO® 90 INFUSION SET 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. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7220-24
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Burning Sensation (2146)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
Three samples of cleo® 90 infusion set were received in unused conditions with the cap seal closed. Samples were visually inspected at a distance of 12" to 24" under normal conditions of illumination. No damage could be detected on the unit. Sample was tested on the skin to see if there was a problem with the adhesive that could cause a problem on the patient's skin. No discrepancies were found. A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct. No root cause could be determined as the complaint was not confirmed.
 
Manufacturer Narrative
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
 
Event Description
It was reported that one day after placing a cleo® 90 infusion set, the patient experienced itching. Upon removing the catheter, the patient noticed there was a burn where the device had been on her abdomen. The patient went to the emergency room where she was prescribed fucidine and pyostacine. The patient also had an echography. The patient switched to a device from a different lot. No permanent injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, 22425
MX 22425
Manufacturer Contact
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6567584
MDR Text Key113435956
Report Number3012307300-2017-01030
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2021
Device Catalogue Number21-7220-24
Device Lot Number76X051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/15/2017 Patient Sequence Number: 1
-
-