MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8LPC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	05/30/2020
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, the unit had cuff inflation/deflation issue.There was no patient harm associated with this event.
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 unit's cuff was tested before placing the cannula on the patient and worked fine.But when the cannula was placed on the patient, the doctor could not insufflate cuff.The doctor tried a lot of times without success.When the device was withdrawn, the cuff was found broken.The patient had a replacement of the tube.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32590 ; MX 32590
• MDR Report Key: 10162597
• Report Number: 2936999-2020-00426
• Device Sequence Number: 2681218
• Product Code: JOH
• UDI-Device Identifier: 60884522007141
• UDI-Public: 60884522007141
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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 Expiration Date: 01/09/2024
• Device Model Number: 8LPC
• Device Catalogue Number: 8LPC
• Device Lot Number: 19A0186JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/03/2020
• 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: 65 YR