MAUDE Adverse Event Report: COVIDIEN SHILEY ORAL/NASAL TRACHEAL TUBE CUFFLES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 86233

Device Problems Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 07/02/2022

Event Type  malfunction  

Event Description

After insertion of the tube the numbers were noted to be going in the wrong numerical order.The adaptor was on the wrong end of the tube.The tube was exchanged.Fda safety report id # (b)(4).

• Brand Name: SHILEY ORAL/NASAL TRACHEAL TUBE CUFFLES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 15016017
• MDR Text Key: 296009184
• Report Number: MW5110851
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/11/2022

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 Model Number: 86233
• Device Lot Number: 21D0536JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 53 KG