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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CLEO 80 INFUSION SET; SUBCUTANEOUS INFUSION SET
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SMITHS MEDICAL CLEO 80 INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/22/2014
Event Type  malfunction  
Event Description
Distributor reported on behalf of homecare user that during removal of the listed device from use, the cannula broke away from the infusion set and remained under the user's skin.No additional medical intervention was reported.No adverse effects to patient reported.
 
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.Manufacturer's reference: (b)(4).
 
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Brand Name
CLEO 80 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 Key3963944
MDR Text Key21875517
Report Number2183502-2014-00332
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 Other
Type of Report Initial
Report Date 05/22/2014
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 FDA05/22/2014
Distributor Facility Aware Date04/22/2014
Event Location Home
Initial Date Manufacturer Received 04/22/2014
Initial Date FDA Received05/22/2014
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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