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

Model Number	10CN10R
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	12/09/2021
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, the physician placed the first cannula but figured out immediately after placement that the cuff was broken and the same with the second cuff.Before placing the third, the physician inflated the cuff, and again the cuff broke.After this, the physician placed a smaller one, size 8.Until today there are no issues.

• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 13090679
• Report Number: 8020889-2021-00174
• Device Sequence Number: 5710956
• Product Code: JOH
• UDI-Device Identifier: 10884521205475
• UDI-Public: 10884521205475
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K150844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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 Model Number: 10CN10R
• Device Catalogue Number: 10CN10R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/27/2021
• 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
• Patient Sex: Unknown