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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 Problem Material Fragmentation (1261)
Patient Problems Hyperglycemia (1905); Device Embedded In Tissue or Plaque (3165)
Event Date 03/31/2017
Event Type  Injury  
Manufacturer Narrative
Twenty-six devices were returned for evaluation in unused condition, twenty within the original packaging and six without the original packaging. Visual inspection of the devices did not find any anomalies. Functional testing involved simulated use testing and did not detect detachment or cannula removal. 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. Based on the evidence, a root cause was unable to be confirmed. No fault was found with the returned 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.
 
Event Description
It was reported that the catheter of a cleo® 90 infusion set broke off and the needle remained in the body of the patient. The device had been in use for three days. The patient's blood glucose levels "constantly increased" at the time of the reported event. The needle was surgically removed in the hospital. No permanent injury was reported.
 
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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
lisa perz
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key6517208
MDR Text Key112227559
Report Number3012307300-2017-00895
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
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 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/23/2021
Device Catalogue Number21-7231-24
Device Lot Number76X192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2017
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 Manufactured12/02/2016
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: 04/24/2017 Patient Sequence Number: 1
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