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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 21-7220-24
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/23/2017
Event Type  malfunction  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that the cannula of a cleo® 90 infusion set remained in the patient's skin after removal of the site. It was confirmed that there were no signs of infection at the site. The patient's blood glucose levels were not impacted. The cannula had not been removed, the patient was going to consult their healthcare provider at their next regularly scheduled office visit. 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
22425
MX 22425
Manufacturer Contact
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6696425
MDR Text Key79365300
Report Number3012307300-2017-01439
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Reporter Occupation
Type of Report Initial
Report Date 07/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Expiration Date10/12/2021
Device Catalogue Number21-7220-24
Device Lot Number76X166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/10/2017 Patient Sequence Number: 1
Treatment
HUMALOG INSULIN
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