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

Model Number 8DFEN

Device Problems Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

When in the operating room for tracheostomy and percutaneous endoscopic gastrostomy, the first shiley tracheostomy tube (size 8) balloon was noted to have a hole in it.A second shiley tracheostomy tube (size 8) was opened and this balloon was noted to have a huge hole as well.A different size shiley trach was obtained and placed with no issues.Per post-op note: anesthesia deflated the et tube balloon and a tracheotomy was made between the first and second tracheal rings.It was then dilated using a tracheal spreader.Under direct visualization, the et tube was backed out and an 8 fenestrated tracheostomy tube was placed into the tracheal defect.On reconnecting to the circuit, it was noted that there was a leak in the balloon.Therefore, the tracheostomy was removed and the et tube was advanced under direct visualization.The patient was re-oxygenated and then under direct visualization, the et tube was again backed out and a second fenestrated tracheostomy was placed without difficulty.The circuit was connected and the patient was oxygenating well.

• 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: 12383811
• MDR Text Key: 268678356
• Report Number: 12383811
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8DFEN
• Device Catalogue Number: 8DFEN
• Device Lot Number: 20L0768JZX
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 97