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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY TUBE
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PORTEX; TRACHEOSTOMY TUBE Back to Search Results
Model Number 101/810/090CZ
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Serious Injury
Event or Problem Description
With a total of 3 tracheal cannulae, it was not possible to perform a complete block with the help of the cuff during use.Only after the cuff was completely unblocked was it possible to perform another blockage, but this condition did not last.Furthermore, there was fluid in the cuff balloon and the supply line.No adverse patient effects were reported.
 
Additional Manufacturer Narrative
Corrected data: type of reportable event corrected to reflect serious injury.
 
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Brand Name
PORTEX
Common Device Name
TRACHEOSTOMY TUBE
MDR Report Key11682879
Report Number3012307300-2021-03229
Device Sequence Number2935602
Product Code BTO
UDI-Device Identifier15019517076325
UDI-Public15019517076325
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K173384
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/17/2021
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? Yes
Operator of Device Health Professional
Device Model Number101/810/090CZ
Device Catalogue Number101/810/090CZ
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/17/2021
Supplement Date Received by Manufacturer04/16/2021
Initial Report FDA Received Date04/16/2021
Supplement Report FDA Received Date04/17/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device N
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
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