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

Model Number	80XLTCP
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the trach tube was placed and anesthesia vent circuit was connected.The patient was not able to be ventilated, and there was no end tidal co2 and the patient experienced transient 02 desaturation.Trach tube was inspected and confirmed to be in correct position in the trachea with balloon inflated.Attempted to ventilate the patient through this tube but continued to be unsuccessful.The trach tube was quickly removed and a reinforced ett was immediately placed into the tracheal stoma successfully leading to the ability to ventilate the patient.The patient's 02 saturation quickly improved to baseline.At this time, a new and different trach tube was successfully placed and connected to the vent circuit without issue.The device was inspected and the inner cannula of this tube appeared to be severely damaged/kinked that led to inability to ventilate the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13711579
• Report Number: 8020889-2022-00059
• Device Sequence Number: 5333389
• Product Code: JOH
• UDI-Device Identifier: 10884522027915
• UDI-Public: 10884522027915
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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: 80XLTCP
• Device Catalogue Number: 80XLTCP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown