MAUDE Adverse Event Report: COVIDIEN LP SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2021

Event Type  malfunction  

Event Description

An incorrect size of inner cannula was placed on a patient.Also, the trach had a reusable inner and was replaced with a disposable.These "new disposable" trachs are almost impossible to read and should not have 3 different sizes listed on the flange.I feel this error is going to be happening a lot.The manufacturer needs to be notified.(b)(6) has recently revised their tracheostomy tubes.That revision includes a phalange that is now clear with new labeling.On the phalange, there is a very large number- outer diameter of the tracheostomy tube- not trach size.There is also another large number- inner diameter of the inner cannula- not trach size.The trach size is printed on the right side of the phalange.The print is very small and difficult to read.Also listed in this area is whether is tube is cuffed or uncuffed, along with an "h" for disposable inner cannula and "r" for reusable inner cannula- numbers and lettering are very small- difficult to even read when you hare holding the trach in your hand.The different numbers and symbols on the phalange (along with small size) can be confusing.Another concern with placement of a disposable inner cannula in a trach that should have a reusable inner cannula is that if the patient were discharged and attempted to repeatedly clean the disposable inner cannula.The disposable inner cannula would degrade with repeated cleaning.This was included in staff education prior to the launch of the product.

• Brand Name: SHILEY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12623276
• MDR Text Key: 276159209
• Report Number: 12623276
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/27/2021,09/21/2021

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: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1