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

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.

• 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 Key: 4008356
• MDR Text Key: 4954521
• Report Number: 3023468-2014-00001
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: TP100
• Device Catalogue Number: TP100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2013
• Initial Date FDA Received: 07/11/2014
• 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 Number: 1
• Patient Outcome(s): Required Intervention