MAUDE Adverse Event Report: MMJ, S.A. DE C.V. MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18880
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	05/25/2018
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, while in use on a patient, there was an air leak from the cuff which was observed at the time of initial cuff check.It was also reported that the cuff pressure did not elevate upon applying air to the cuff.Customer indicated that recannulation of a replacement tube was required.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue was confirmed.An inflation/deflation test was performed 25cc of air was applied to the cuff using a syringe and it was observed the cuff deflated immediately.A visual inspection was performed, and it was observed the cuff presents a small tear.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, S.A. DE C.V.; ave. henequen no 1181 desarrol; ciudad juarez CI 32 590; MX CI 32590
• MDR Report Key: 7592614
• Report Number: 2936999-2018-00385
• Device Sequence Number: 167598
• Product Code: BTR
• UDI-Device Identifier: 30884521032549
• UDI-Public: 30884521032549
• 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: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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 Model Number: 18880
• Device Catalogue Number: 18880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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