MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4CN65A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Pulmonary Emphysema (1832)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, the tracheostomy tube kept popping out.The event resulted for the patient to experience barotrauma and surgical emphysema.The device was explanted.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• MDR Report Key: 11920091
• Report Number: 8020889-2021-00051
• Device Sequence Number: 3179000
• Product Code: JOH
• UDI-Device Identifier: 10884521172456
• UDI-Public: 10884521172456
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2025
• Device Model Number: 4CN65A
• Device Catalogue Number: 4CN65A
• Device Lot Number: 20C0962JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR