MAUDE Adverse Event Report: COVIDIEN LP SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBE WITH TAPERGUARD CUFF; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 8CN85H

Device Problems Product Quality Problem (1506); Gas/Air Leak (2946); Noise, Audible (3273)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/20/2022

Event Type  malfunction  

Event Description

The patient had a tracheostomy tube size 8 inserted without difficulty.Eight days later at 1111, the rn noticed an audible leak coming from the patient's tracheostomy.The patient began to experience decreasing oxygen saturations requiring an increase in oxygen.The respiratory therapist and rn assessed the patient and recommended increasing the peep from 10 to 12 cm h20.It was determined the cuff was not holding air and the physician replaced the tracheostomy with the same style of tube and size.At 1500, the rn began hearing a leak from the tracheostomy, and cuff pressure was measured by rt.The rt replaced some air due to cuff pressure being below the previous measurement.By 2130, the patient was being placed back in bed and rn documented that the cuff "popped".The tracheostomy was replaced by the physician for the 2nd time.Several days later, at 0830, the tracheostomy was replaced due to a persistent leak.It was noted the 3rd tracheostomy did not have the same lot number as replacement tracheostomy #1 and #2.The 3rd tracheostomy remains in place without any issues.The patient did not have any anatomical malformation of the airway.The manufacturer sent questions regarding the incident and the product to be completed.They would like to have the products sent back to them for analysis team review.

• Brand Name: SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBE WITH TAPERGUARD CUFF
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15334638
• MDR Text Key: 299049889
• Report Number: 15334638
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2022

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 Model Number: 8CN85H
• Device Lot Number: 22C0847JZX
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White