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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 Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/28/2017
Event Type  malfunction  
Manufacturer Narrative
One used cleo® 90 infusion set site was returned for investigation. The site was found to have its soft cannula separated from itself at a location of approximately 2 mm from where it extends out from the base. The remaining length of cannula was not returned. Upon closer visual examination, the distal end of the cannula (attached to the site) was found to have been 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 signs of having any damage and there was no evidence to suggest the event was caused from an intrinsic defect in the product.
 
Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed. Device evaluation in progress.
 
Event Description
It was reported that when removing a cleo® 90 infusion set, the cannula broke off in the patient's thigh. The device had been in use for 24 hours prior to the event. The cannula was removed by a nurse. The infusion set was being used to infuse apokinon. No permanent injury was reported.
 
Event Description
It was further reported that the patient did not experience an adverse health outcome and medical intervention was not needed. The event was considered resolved.
 
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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
7633833074
MDR Report Key6513766
MDR Text Key249760403
Report Number3012307300-2017-00871
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 foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2017
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 Number76X163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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