MAUDE Adverse Event Report: COVIDIEN COVIDIEN ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 808910 TUBE ENDO CUFFED 8.0 *LF

Device Problem Gas/Air Leak (2946)

Patient Problems Bradycardia (1751); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

A (b)(6)-year-old man with past medical history notable only for obesity admitted with covid pneumonia, which deteriorated to the point where he had acute severe hypoxemic respiratory failure/ards despite treatment with decadron and remdesivir.He was intubated with a size 8 ett at 12:49 pm on (b)(6) 2021.Overnight he developed a cuff leak while prone, which necessitated reintubation with a size 8 ett at 01:01 am on (b)(6) 2021, followed by insertion of a left ij catheter.He had also been experiencing intermittently bradycardia into the 30s which episodically continued, possibly caused by left ij, with any motion, or repositioning of ett and irritation at carina.The patient responded appropriately to epinephrine, atropine and support with levophed.At 17:00, the patient developed a second, spontaneous cuff leak and a new ett was exchanged over a bougie using a 7.5 from different stock.At 19:00, he was transferred to a tertiary medical center for possible ecmo.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN ENDOTRACHEAL TUBE
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11790093
• MDR Text Key: 249773007
• Report Number: MW5101232
• Device Sequence Number: 1
• Product Code: BTR
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 808910 TUBE ENDO CUFFED 8.0 *LF
• Device Catalogue Number: COVIDIEN 187805
• Device Lot Number: 20H0627JZX
• Date Returned to Manufacturer: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 39 YR
• Patient Weight: 94