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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE TRACHEOSTOMY AND TUBE CUFF
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 100/870/060CZ
Device Problem Pressure Problem (3012)
Patient Problem No Information (3190)
Event Date 08/12/2020
Event Type  Injury  
Event Description
Information was received indicating that a smiths medical tracheotomy cuff wasn't keeping air pressure after using the cuff pressure gauge.There were no adverse events reported.
 
Manufacturer Narrative
Corrected data: changed from malfunction to a serious injury.
 
Manufacturer Narrative
Under visual inspection the sample appeared to be in good condition.During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received samples.It was confirmed that after 12 hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed.No trend of similar customer complaints was identified.
 
Event Description
Investigation completed and summarized in h 10.
 
Manufacturer Narrative
Under visual inspection the sample appeared to be in good condition.During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received samples.It was confirmed that after 12 hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed.No trend of similar customer complaints was identified.
 
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Brand Name
PORTEX
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ  753 01
MDR Report Key10541433
MDR Text Key207168308
Report Number3012307300-2020-09390
Device Sequence Number1
Product Code BTO
UDI-Device Identifier15019315104831
UDI-Public15019315104831
Combination Product (y/n)N
PMA/PMN Number
K030570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number100/870/060CZ
Device Lot Number3817662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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