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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7231-24
Device Problems Fluid Leak (1250); Material Fragmentation (1261)
Patient Problems Skin Irritation (2076); Chemical Exposure (2570); Device Embedded In Tissue or Plaque (3165)
Event Date 05/02/2017
Event Type  malfunction  
Manufacturer Narrative
Three devices were returned for evaluation in unused condition. Visual inspection of the devices found no anomalies. Functional testing involved simulation testing and did not detect detachment or cannula removal issues. A review of the testing and inspection documents was performed and deemed adequate and correct. A review of the manufacturing process was performed on a similar part and found no discrepancies. Three devices from the manufacturing line were functionally tested and detected no detachment or cannula removal issues. Based on the evidence, a root cause was unable to be determined. No fault was found with the devices.
 
Manufacturer Narrative
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed. Device evaluation in progress.
 
Event Description
It was reported that the plastic cannula of a cleo® 90 infusion set broke off inside the patient's abdomen during infusion set removal. The fault was noticed by the patient's wife and home care nurse. The site had been cleaned with chlorhexidine prior to insertion. The set had been in use for 24 hours at the time of the event. As a result of the event, apomorphine flowed back out of the cannula and onto the patient's skin, which caused small wounds around the infusion set site. It was observed that the wounds looked "calm" and were healing. The patient consulted with a medical specialist regarding the event. The medical specialist decided not to remove the cannula, and to let the cannula "outgrow" itself. No permanent injury was reported. See mfr: 3012307300-2017-01121 and 3012307300-2017-01124.
 
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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 Key6591673
MDR Text Key106209161
Report Number3012307300-2017-01123
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/08/2022
Device Catalogue Number21-7231-24
Device Lot Number77X005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2022
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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