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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEEVERS MFG. & SUPPLY, INC. TILSON TRACH GUARD

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BEEVERS MFG. & SUPPLY, INC. TILSON TRACH GUARD Back to Search Results
Model Number TP100
Device Problem Connection Problem (2900)
Patient Problem Respiratory Distress (2045)
Event Date 12/05/2013
Event Type  malfunction  
Event Description
I implemented using the trach guard around a year ago at my institution in response to a critical incident taking place on a patient.I had used them in the 90's at (b)(6) hosp of (b)(6) and brought them here after the event.As fate would have it we had another event using the trach guard (and unbelievably happened to the same patient).I would love the opportunity to speak with you about it to bring you into the loop and also to see if we could make a modification to the current device or design something different to prevent either of the past events we have experienced here from happening again.
 
Manufacturer Narrative
When the aerosol tubing becomes disconnected from the trach mask, a caregiver may with some ingenuity attach the aerosol tubing directly to the trach guard and to the cuffed trach rather than the trach mask.If this aerosol set up has no pop off inline, the patient has no way to exhale and may develop a pneumothorax.In this case, the caregiver mistakenly was connecting aerosol tubing directly to a trach guard making a pressure-tight seal.In order to do this the connector must be inserted over the trach guard at an angle.We will add to the instructions a warning not to use the trach guard as an airway connector.It is only for use to protect an open airway from accidental occlusion.
 
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Brand Name
TILSON TRACH GUARD
Type of Device
TRACH GUARD
Manufacturer (Section D)
BEEVERS MFG. & SUPPLY, INC.
mcminnville OR
Manufacturer Contact
tim beevers
850 sw booth bend rd
mcminnville, OR 97128
5034729055
MDR Report Key4008356
MDR Text Key4954521
Report Number3023468-2014-00001
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Relabeling
Type of Report Initial
Report Date 06/25/2014
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? No
Device Operator Health Professional
Device Model NumberTP100
Device Catalogue NumberTP100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2013
Initial Date FDA Received07/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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