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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY
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PORTEX; TRACHEOSTOMY Back to Search Results
Model Number 8.0 MM
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Code Low Oxygen Saturation (2477)
Date of Event 02/27/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes pdt uniperc was leaking from the channel by pilot balloon and cuff.Weak occurred during patient usage as tidal volumes was not being achieved.Ent was consulted and urgent assessment was made for tracheotomy tube exchange.Size 8 was exchanged and cuff pressure checked with no leak.
 
Additional Manufacturer Narrative
Other, other text: additional information: h10: information was received indicating that no adverse sequelae for the patient.The tube was removed, checked tube and leak was noted in pilot line 1cm above cuff.
 
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Brand Name
PORTEX
Common Device Name
TRACHEOSTOMY
MDR Report Key11646683
Report Number3012307300-2021-03047
Device Sequence Number11487962
Product Code BTO
UDI-Device Identifier15019315107207
UDI-Public15019315107207
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K083031
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/12/2021
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 No Information
Device Expiration Date06/23/2025
Device Model Number8.0 MM
Device Catalogue Number100/897/080CZ
Device Lot Number4031397
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/12/2021
Supplement Date Received by Manufacturer04/14/2021
Initial Report FDA Received Date04/11/2021
Supplement Report FDA Received Date05/12/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
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 Initial
Patient Sequence Number1
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