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

Model Number	60XLTIN
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/30/2018
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, the patient came back from endoscopy and after the device was placed, the patient developed respiratory distress.A plug was suspected and they tried to bag and suction the patient.They were unable to pass the suction catheter.The existing inner cannula was removed and found to have a kink/deformation in the tube that severely limited the size of the inner lumen.Once a new inner cannula was placed they were able to bag and suction properly and return the patient to baseline.The original inner cannula was determined to be the cause due to deformation/kink.Nothing actually occurred with the tube.Only the inner cannula was noted as the cause.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 8128633
• Report Number: 8020889-2018-00135
• Device Sequence Number: 19224694
• Product Code: JOH
• UDI-Device Identifier: 40884522006720
• UDI-Public: 40884522006720
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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 Model Number: 60XLTIN
• Device Catalogue Number: 60XLTIN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/04/2018
• 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