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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 8DFEN
Medical Device Problem Code Defective Component (2292)
Health Effect - Clinical Code Unintended Extubation (4564)
Date of Event 08/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Uf/importer rpt num: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during tracheostomy and percutaneous endoscopic gastrostomy, the balloon of the device had a hole.A second device was opened and the balloon had a huge hole as well.A different size of the tube was obtained and placed with no issues.
 
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Brand Name
SHILEY
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
MDR Report Key12517036
Report Number2936999-2021-00951
Device Sequence Number20120237
Product Code JOH
UDI-Device Identifier10884522006675
UDI-Public10884522006675
Combination Product (Y/N)N
Initial Reporter StateOH
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 User Facility
Report Source health professional,user faci
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/22/2021
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 Date12/16/2025
Device Model Number8DFEN
Device Catalogue Number8DFEN
Device Lot Number20L0768JZX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/22/2021
Date Device Manufactured12/16/2020
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
Patient Age74 YR
Patient Weight97
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