MAUDE Adverse Event Report: COVIDIEN SHILEY 8PERC; TRACHEOSTOMY, TUBE (W/WO CONNECTOR)

Model Number 8 PERC

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/23/2019

Event Type  malfunction  

Event Description

Shiley #8perc tracheostomy tube was placed on (b)(6) 2019 at 21:29 via percutaneous procedure using bronchoscopy by (b)(6).On (b)(6) 2019 respiratory therapist was called to patient bedside by rn and noted that the top part of the trach flange had separated from the tracheostomy tube.Patient currently on mechanical ventilation with no loss of volume.The patient had coagulation issues and there was bleeding at the trach site.Sutures were placed around the trach site by (b)(6), and a decision was made to replace the trach tube next day due to coagulation issues.On (b)(6) 2019 at 12:58 the tracheostomy tube was changed via bronchoscopy with a size 6 dct.Respiratory therapist was told by another nurse of a similar event on another patient where an 8perc trach was cracked in the same place and was changed to a 6dct.It was also discovered that another respiratory therapist has had at least 2 other perc trachs that were cracked on insertion.None of these tracheostomy tubes were saved or reported.Fda safety report id # (b)(4).

• Brand Name: SHILEY 8PERC
• Type of Device: TRACHEOSTOMY, TUBE (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9539827
• MDR Text Key: 173658124
• Report Number: MW5091985
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8 PERC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 87