MAUDE Adverse Event Report: RUSCH / WILLY RUSCH GMBH RUSCH QUICKTRACH; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2021

Event Type  malfunction  

Event Description

While using device as trained and directed by manufacture, the rusch quicktrach failed to pierce the skin of the neck without very significant pressure and force which led to failed and improper placement of device; 2 attempts were made and the device required excessive force to puncture the skin.Fda safety report id # (b)(4).

• Brand Name: RUSCH QUICKTRACH
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): RUSCH / WILLY RUSCH GMBH
• MDR Report Key: 13720429
• MDR Text Key: 287000577
• Report Number: MW5107996
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White