MAUDE Adverse Event Report: COVIDIEN SHILEY LO-PRO ORAL/NASAL TRACHEAL TUBE CUFFED; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 0120884522000243

Device Problems Deflation Problem (1149); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

The cuff does not stay inflated.Tested 3 et tubes with the same lot# and had the same result.Fda safety report id # (b)(4).

• Brand Name: SHILEY LO-PRO ORAL/NASAL TRACHEAL TUBE CUFFED
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 15493652
• MDR Text Key: 300704631
• Report Number: MW5112267
• Device Sequence Number: 1
• Product Code: JOH
• 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: 09/22/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0120884522000243
• Device Catalogue Number: 86051
• Device Lot Number: 22G0343JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic