MAUDE Adverse Event Report: COVIDIEN LP JUAREZ (MMJ) SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	8PERC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/09/2020
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, during use, the wings which secure inner cannula to trach flanges was broken.Re-intubation was required.It was replaced with an identical tracheostomy tube (8.0 cuffed).

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 10359932
• Report Number: 2936999-2020-00557
• Device Sequence Number: 13690790
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K884730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 8PERC
• Device Catalogue Number: 8PERC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• 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: 32 YR
• Patient Weight: 36