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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 100/870/075
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/01/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu) cuff deflated after one day, he reported putting air in again and the cuff deflated again.No patient injury was reported.
 
Additional Manufacturer Narrative
Corrected data: updated on correct aware date.
 
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
PORTEX
Common Device Name
TRACHEOSTOMY
MDR Report Key11205198
Report Number3012307300-2021-00601
Device Sequence Number2551271
Product Code BTO
UDI-Device Identifier15019315038792
UDI-Public15019315038792
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K030570
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date (Section B) 03/28/2021
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 Model Number100/870/075
Device Catalogue Number100/870/075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/21/2020
Supplement Date Received by Manufacturer12/21/2020
02/25/2021
Initial Report FDA Received Date01/20/2021
Supplement Report FDA Received Date01/20/2021
03/27/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
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
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