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

Model Number	110875
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a communication that there was a leak on the cuff of one tube.The customer indicated that a change of the tube was required.
Additional Manufacturer Narrative
One sample was received for analysis and the reported issue could not be confirmed.A visual inspection was performed and it was observed all the components were assembled according to manufacturing process.An inflation/deflation test was performed and the cuff held the air.The sample was submerged into a container filled with water and no leaks were observed after 4 hours of testing.We are unable to determine the cause for this specific event however; manufacturing controls are in place to detect damage and to reduce the potential for occurrence during the manufacturing process.A device history record review was performed; all records indicated that the product was released accomplishing all quality requirements.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a communication that there was a leak on the cuff of one tube.The customer indicated that a change of the tube was required.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 6809184
• Report Number: 8020889-2017-05108
• Device Sequence Number: 132691
• Product Code: BTR
• UDI-Device Identifier: 20884521068220
• UDI-Public: 20884521068220
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 12/01/2021
• Device Model Number: 110875
• Device Catalogue Number: 110875
• Device Lot Number: 201612061X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 11/09/2017
• 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