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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Model Number 100/860/080
Device Problem Gas/Air Leak (2946)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/12/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
Event Description
It was reported that the patient was admitted to the hospital for cerebral hemorrhage and was treated surgically at 09:00 on (b)(6) 2022 in accordance with the doctor's instructions, and the patient was intubated and equipped with sputum suction tracheostomy during the operation.The airbag leakage phenomenon was found and was replaced immediately, causing secondary puncture injury to the patient.No other additional information has been provided at this time.
 
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Brand Name
PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE
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
muping district
minneapolis, MN 55442
MDR Report Key15651834
MDR Text Key306929516
Report Number3012307300-2022-25740
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K030570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/21/2022
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 Number100/860/080
Device Catalogue Number100/860/080CZ
Device Lot Number3996106
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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