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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 Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/01/2017
Event Type  malfunction  
Manufacturer Narrative
Three unused cleo® 90 infusion sets were returned for investigation. Examination of the entire devices found no abnormalities or defects. The trocar was in proper position as was the site, soft cannula, etc. Microscopic examination of the soft cannulas were all found to be in proper order with no visual defects or abnormalities. No device issues were found. No root cause for reported problem was determined.
 
Manufacturer Narrative
It was reported that the event occurred at the end of (b)(6) 2017. The exact date is unknown. 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 remained in the patient's skin. The device had been in use for "three days or more" when the fault occurred. It was noted that the nurse went to the patient's home later, and the "catheter set" had been done successfully. The cannula worked itself out of the skin. 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 Key6729401
MDR Text Key194888423
Report Number3012307300-2017-01551
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 distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Catalogue Number21-7231-24
Device Lot Number76X159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
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 Manufactured10/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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