MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4.0PDC
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that during patient use the pilot balloon deflated.The customer reported recannulation with a replacement tube was required and there was no patient harm.
Additional Manufacturer Narrative
One sample of pediatric tracheostomy tube cuffed part number 4.0pdc was received for evaluation.Inflation/deflation testing verified the cuff deflated after few seconds.Visual inspection confirmed a cut in the blue cover of the pilot balloon which would have been detected immediately in the manufacturing process.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.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that during patient use the tubes pilot balloon deflated.The customer reported that there was no patient harm.The customer reported that during patient use recannulation of a replacement tube was required.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6873970
• Report Number: 2936999-2017-05475
• Device Sequence Number: 800544
• Product Code: JOH
• UDI-Device Identifier: 20884522029107
• UDI-Public: 20884522029107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: 01/25/2022
• Device Model Number: 4.0PDC
• Device Catalogue Number: 4.0PDC
• Device Lot Number: 17A0611JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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