MAUDE Adverse Event Report:; TRACHEOSTOMY DEVICE

Device Problems Kinked (1339); Material Integrity Problem (2978)

Patient Problems Skin Discoloration (2074); Low Oxygen Saturation (2477)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

The tracheostomy tube (trach) kinked in the patient's neck.The nurse was unable to pass the suction catheter.The trach was emergently changed.The patient's color changed and desaturated.The nurse assessed that metal rings that generally hold the trach were flimsy and too pliable.We were able to bend the trach too easily.

• Brand Name: UNK
• Type of Device: TRACHEOSTOMY DEVICE
• MDR Report Key: 4297058
• MDR Text Key: 5078698
• Report Number: 4297058
• Device Sequence Number: 1
• Product Code: JOH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR