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

Model Number	70XLTCP
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Hypoxia (1918); Unintended Extubation (4564)
Date of Event	01/15/2021
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 device herniated which caused the patient to have a serious issue.Cuff bulged on one side and patient decompensated, went into asystole sleep, o2 dropped enough that heartbeat became irregular, probably the cuff did not seal during surgery resulting in loss of supplied oxygen.Re cannulated and used endotracheal (et) tube, a new trach tube was placed and secured.The patient was injured but recovered.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• MDR Report Key: 11300832
• Report Number: 8020889-2021-00007
• Device Sequence Number: 19018030
• Product Code: JOH
• UDI-Device Identifier: 10884522027908
• UDI-Public: 10884522027908
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: 08/01/2023
• Device Model Number: 70XLTCP
• Device Catalogue Number: 70XLTCP
• Device Lot Number: 201808057X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/09/2021
• 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: 37 YR