MAUDE Adverse Event Report: COVIDIEN 10 FRENCH COVIDIEN DHT

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem Extubate (2402)

Event Date 02/07/2014

Event Type  Injury  

Event Description

Placed 10 french covidien dht immediately after bedside tracheostomy to utilize patients sedated state for improved cohesive care; dht was noted to be in appropriate location (post pyloric) upon first placement attempt via xray confirmation; upon attempt to remove stylette from dht, the dht was noted to crink and stylette did not withdraw.Warm water was flushed through tube in attempt to loosen stylette for removal however this was unsuccessful.Ultimately the dht was removed.Upon doing so, this rn attempted to remove stylette at which point of the top part (green part) of stylette broke off with stylette still broke off with stylette still in dht.New 8 french dht (medsystem) placed without complication.

• Brand Name: 10 FRENCH COVIDIEN DHT
• Type of Device: 10 FRENCH COVIDIEN DHT
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 4387477
• MDR Text Key: 21562624
• Report Number: MW5039967
• Device Sequence Number: 1
• Product Code: JOH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR