MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RCI_ SHERIDAN HVT ENDOTRACHEAL TUBE 8.5MM; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number 5-10317

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

"crna reported to dr.(b)(6), anesthesiologist, difficult to remove ett, redosed propofol for sedation.Dr.(b)(6) removed ett, noted cuff slightly inflated.Cuff deflation failure, dr.(b)(6) informed." fda safety report id# (b)(4).

• Brand Name: HUDSON RCI_ SHERIDAN HVT ENDOTRACHEAL TUBE 8.5MM
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 10152955
• MDR Text Key: 195261412
• Report Number: MW5094975
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Catalogue Number: 5-10317
• Device Lot Number: 73D1700619
• Was Device Available for Evaluation?: Yes
• 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 Age: 62 YR
• Patient Weight: 61