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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BLUE LINE ULTRA CLEANING BRUSH FOR INNER CANNULAE; TUBE, TRACHEOSTOMY

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SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BLUE LINE ULTRA CLEANING BRUSH FOR INNER CANNULAE; TUBE, TRACHEOSTOMY Back to Search Results
Model Number 100/855/000
Device Problem Connection Problem (2900)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/11/2015
Event Type  Injury  
Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
 
Event Description
It was reported that user had been cleaning the tracheostomy tube with the listed brush when the brush head detached from the handle and fell into the patient's lung.The patient was hospitalized to remove the brush, but the first attempt was unsuccessful.Patient was then transferred to another hospital for removal of brush.No permanent adverse effects to patient reported.
 
Manufacturer Narrative
(b)(4) unused brushes were returned for evaluation.The samples were visually inspected.No defects or abormalities were detected on any of the returned samples.In an attempt to reproduce the reported detachment, the samples were pulled by hand.No detachment was observed in any of the samples.There was no evidence found to suggest the event was caused from intrinsic defect in the device.
 
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Brand Name
PORTEX BLUE LINE ULTRA CLEANING BRUSH FOR INNER CANNULAE
Type of Device
TUBE, TRACHEOSTOMY
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL LTD.
boundry road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL LTD.
boundry road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
michele seliga
1265 grey fox rd
st. paul, MN 55112
6516287604
MDR Report Key5117191
MDR Text Key27222298
Report Number2183502-2015-00725
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K030381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Followup
Report Date 10/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/28/2019
Device Model Number100/855/000
Device Catalogue Number100/855/000
Device Lot Number2762686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/01/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/15/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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