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

Model Number	70XLTCD
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, a patient with the diagnosis of covid-19 had a trach placed roughly two weeks ago.A few days after the initial trach change, the patient experienced loss of tidal volume on the ventilator.The trach was removed, and it was noted that there was damage to the cuff.The trach was replaced with another, which was tested with air prior to insertion but subsequently experienced cuff leakage as well.The second trach was removed and replaced.Again, the cuff was tested with air prior to insertion and presently had another leak but had been minimal and managed with the application of an "intellicuff" which was still attached to the pilot balloon.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• MDR Report Key: 12048712
• Report Number: 8020889-2021-00062
• Device Sequence Number: 4359151
• Product Code: JOH
• UDI-Device Identifier: 20884522028162
• UDI-Public: 20884522028162
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 70XLTCD
• Device Catalogue Number: 70XLTCD
• Device Lot Number: 201710221X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR