MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18870
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the tracheostomy tube experienced inflation/deflation issues.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a communication regarding a pilot balloon.According to the reporter, there was a cuff inflation/deflation issue.
Additional Manufacturer Narrative
Evaluation summary: one sample was evaluated and the reported event was confirmed.The product is used in treatment.Product does not meet specification.The reported event was confirmed.The device history record review shows the product was released to specification.The investigation found cuff leakage but the sample was used.The investigation isolated the failure to the following: the most probable root cause is ¿cuff punctured/ ruptured during insertion/use¿ which is as a result of the cuff contact with a sharp/rough surface e.G.Teeth, utensils used during intubation.As stated in the ¿warnings/pre cautions¿ section of the product instructions for use ¿various bony anatomical structures (e.G.Teeth) within the intubation routes or any intubation tools with sharp surfaced present a treat to maintaining cuff integrity¿.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6716206
• Report Number: 2936999-2017-05321
• Device Sequence Number: 13764932
• Product Code: BTR
• UDI-Device Identifier: 30884521032525
• UDI-Public: 30884521032525
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090352
• 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,Followup
• Report Date (Section B): 03/13/2018

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: 08/07/2021
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: 16H0282JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 02/02/2018; 02/20/2018
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 02/19/2018; 03/13/2018
• 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: 66 YR
• Patient Weight: 99