MAUDE Adverse Event Report: COVIDIEN MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18865
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is replacing previous report 2936999-2017-00094.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter right after the patient was intubated, it was difficult to supply air to the cuff.It was reported, post procedure the cuff was not deflated completely but removed from the patient.Customer could not confirm if issue was found during pre-test.There was no patient harm with this event.
Additional Manufacturer Narrative
One sample was received for evaluation; an inflation/deflation test was performed and it was observed inflation and deflation were difficult.Visual inspection observed that the inflation line tubing was collapsed inside the lumen of the tube, thus the reported event was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer states: right after the patient was intubated, it was difficult to supply air to the cuff.It was reported, post procedure the cuff was not deflated completely but removed from the patient.Customer could not confirm if issue was found during pre-test.There was no patient harm wit this event.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN; avenida henequen 1181 parque; industrial salvarcar cd.; juarez
• MDR Report Key: 6804709
• Report Number: 2936999-2017-05413
• Device Sequence Number: 3174913
• Product Code: BTR
• UDI-Device Identifier: 20884521032511
• UDI-Public: 20884521032511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 05/04/2021
• Device Model Number: 18865
• Device Catalogue Number: 18865
• Device Lot Number: 16E0108JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 08/18/2017
• 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