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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUSELECT DILATION TRACHESTOMY KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUSELECT DILATION TRACHESTOMY KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Model Number 101/860/090CZ
Device Problems Break (1069); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2022
Event Type  malfunction  
Event Description
It was reported that during use of the device, an alarm went off and the inflation line was found damaged.No patient injury was reported.
 
Manufacturer Narrative
Other, other text: manufacturing device history record review was not performed because the results of the complaint investigation is a design related problem.A product sample was received for evaluation.Visual inspection was performed.Visual inspection found the inflation line was detached from pilot balloon.The root cause of the reported issue was found to be a design problem.An internal capa has been opened and this issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.
 
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Brand Name
PORTEX BLUSELECT DILATION TRACHESTOMY KIT
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
Manufacturer (Section G)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK   CT21 6JL
Manufacturer Contact
jim vegel
6000 nathan lane north
3-10-15, hakata station east,
minneapolis, MN 55442
MDR Report Key15047892
MDR Text Key304605719
Report Number3012307300-2022-13555
Device Sequence Number1
Product Code BTO
UDI-Device Identifier15019517076172
UDI-Public15019517076172
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K173384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/17/2022
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 Health Professional
Device Model Number101/860/090CZ
Device Catalogue Number101/860/090CZ
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/28/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/23/2022
Initial Date FDA Received07/18/2022
Supplement Dates Manufacturer Received07/19/2022
Supplement Dates FDA Received08/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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