MAUDE Adverse Event Report: MEDTRONIC (COVIDEN) / COVIDIEN COVIDEN SHILEY ENDOTRACEAL TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number COVIDEN 187805

Device Problem Deflation Problem (1149)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hematemesis (4478)

Event Date 11/03/2021

Event Type  Injury  

Event Description

A (b)(6) year old male with history of alcohol abuse presented to the ed with hematemesis.In the ed, he vomited 1 liter of blood and became hypotensive with a sbp of 80.He was intubated for airway protection.The balloon on the endotracheal tube was inflated before the procedure without an issue.A #8 ett was placed using a glidescope.The balloon filled after intubation.The respiratory therapist noted within 30 seconds that the balloon had deflated.Attempted to re-inflate times 3 but deflated each time.The ett was removed and a new tube was inserted.The patient did not sustain an injury.We currently have the tube and packaging.We will provide it to the manufacturer if they would like to have it.Fda safety report id # (b)(4).

• Brand Name: COVIDEN SHILEY ENDOTRACEAL TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MEDTRONIC (COVIDEN) / COVIDIEN
• MDR Report Key: 12814107
• MDR Text Key: 280870992
• Report Number: MW5105302
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: COVIDEN 187805
• Device Lot Number: 21A0299JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White