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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
Device Problem Detachment Of Device Component (1104)
Patient Problems Inflammation (1932); Device Embedded In Tissue or Plaque (3165)
Event Date 01/01/2017
Event Type  malfunction  
Manufacturer Narrative
Thirteen used cleo 90 infusion sets and one photo were received for investigation. The samples were visually inspected and it was revealed that eleven samples had detached cannulas and two samples had bent cannulas. The complaint was confirmed. A manufacturing review was performed and produced samples were tested and no detachment was detected in any of the tested samples and the cannula was not removed from the site. The root cause was determined to be a manufacturing error that caused the device to be improperly assembled.
 
Manufacturer Narrative
It was reported that the event occurred in 2017. The exact date is unknown. Potential catalog number: 21-7231 24, potential lot number: 77x013. 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 detached from the site and remained in the patient's skin. The patient's right upper thigh was noted to have a "red thickening" due to inflammation from the cannula. 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 Key6753867
MDR Text Key196335527
Report Number3012307300-2017-01649
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 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2018
Was Device Evaluated by Manufacturer? Yes
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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