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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
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SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 8DCT
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Code Unintended Extubation (4564)
Date of Event 07/10/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during use, an audible leak was heard and the patient was losing tidal volume.A blown cuff was discovered from the patient tube.An emergency device change was done using the same type and size of device.The patient was reassessed and the tidal volume was stabled.The device was submerged with water to locate the leak and it was found between the device cuff and pilot airline connection.
 
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Brand Name
SHILEY
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
MDR Report Key12652818
Report Number9681384-2021-00032
Device Sequence Number4480770
Product Code JOH
UDI-Device Identifier20884522029022
UDI-Public20884522029022
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K962173
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 10/18/2021
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
Operator of Device Health Professional
Device Expiration Date03/29/2026
Device Model Number8DCT
Device Catalogue Number8DCT
Device Lot Number21C1124JZX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2021
Initial Report FDA Received Date10/18/2021
Date Device Manufactured03/29/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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