MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	8PERC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/24/2016
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 patient came to change metallic cannula number 6 by polyvinyl to start a new treatment - radiotherapy, when changing had bleeding and treatment did not progress.It is necessary to place the portex on returning from radiotherapy, bleeding back only being possible to place the metallic cannula 5 then, forwarded to head and neck section.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• MDR Report Key: 11306838
• Report Number: 8020889-2021-00008
• Device Sequence Number: 11609044
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K884730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 8PERC
• Device Catalogue Number: 8PERC
• Device Lot Number: 15D0564J2X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1