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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 21-7230-24
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/19/2017
Event Type  Injury  
Manufacturer Narrative
One used cleo® 90 infusion set was received for investigation. The used site was found to have its soft cannula separated from itself at a location of approximately 1mm from where it extends out from the base. Upon closer examination, the distal end of the cannula was found to be slightly bent over one side. There were no visual abnormalities in the wall thickness of the cannula, nor was there any defects in the device itself other than the missing cannula length. The crown of the site showed no sign of having any damage and there was no evidence found to suggest the event was caused from an intrinsic defect in the product. No root cause was determined.
 
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 when removing a cleo® 90 infusion set, the cannula remained in the patient's skin. The cannula still remains in the patient's body as the patient did not wish to have an operation. No inflammation was observed. 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
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6567138
MDR Text Key106206611
Report Number3012307300-2017-01023
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2017
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 Date11/09/2021
Device Catalogue Number21-7230-24
Device Lot Number76X183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2016
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: 05/15/2017 Patient Sequence Number: 1
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