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 Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
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, sometime after intubation, air was supplied to the cuff but the device¿s cuff was not inflated.Recannulation of a replacement tube was required.Customer indicated that there was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation, an inflation/deflation test was performed and it was observed the cuff deflated after few seconds, a visual inspection was performed, and it was observed the inflation line presents damage, the failure mode leak at inflation line is confirmed.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.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7526027
• Report Number: 2936999-2018-00349
• Device Sequence Number: 1305184
• Product Code: BTR
• UDI-Device Identifier: 20884521032528
• UDI-Public: 20884521032528
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 09/20/2021
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: 16I0444JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 05/12/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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