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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CLEO 90 INFUSION SET; SUBCUTANEOUS INFUSION SET
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SMITHS MEDICAL CLEO 90 INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2014
Event Type  malfunction  
Event Description
Distributor reported on behalf of home-care pt stating that a father was removing his son's device, when he noticed the cannula broke off of the administration set.It is unk if the cannula remained under the pt's skin.The pt did not receive medical intervention for exploration or removal of the cannula.No permanent adverse effects to pt reported.
 
Manufacturer Narrative
Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated the mfr will file a follow up report detailing the results of the eval.
 
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Brand Name
CLEO 90 INFUSION SET
Type of Device
SUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
SMITHS MEDICAL
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4465596
MDR Text Key5188895
Report Number2183502-2014-01103
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2015,01/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/23/2015
Distributor Facility Aware Date12/10/2014
Event Location Home
Initial Date Manufacturer Received 01/06/2015
Initial Date FDA Received01/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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