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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATOS MEDICAL INC. TRACOE SILCOSOFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
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ATOS MEDICAL INC. TRACOE SILCOSOFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Catalog Number REF 373-C
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2023
Event Type  malfunction  
Event Description
Tracoe silicosoft ref 373-c ped size/id 4.0, od 6.0, l 55mm- leaks from top of cuff where the cuff connects to outer lumen of trach.October 2022: fda alerts that there is a worldwide silicone shortage due to an issue with the raw material used to manufacture silicone.Bivona and tracoe trachs that are almost exclusively used in the neonatal and pediatric population were difficult to order due to this.As our trach supply was getting lower, we needed to find a way to process the trachs in house.Two months later we were able to create 2 separate methods to process inpatient trachs during the supply issue following the ifus for each trach.A part of the pre-use check with reprocessed trachs is to check the integrity of the cuff and instill sterile water for the check.This was when it was noticed to be leaking.
 
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Brand Name
TRACOE SILCOSOFT TRACHEOSTOMY TUBE
Type of Device
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
ATOS MEDICAL INC.
2801 s moorland rd
new berlin WI 53151
MDR Report Key16860217
MDR Text Key314467525
Report Number16860217
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberREF 373-C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2023
Event Location Hospital
Date Report to Manufacturer05/03/2023
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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