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

Model Number	18875
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2018
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, the device cuff started to leak after few hours.It was reported that it was tested without incident.It was reported that re-cannulation of a replacement tube was unknown.The customer reported that patient outcome was asked but unknown.
Additional Manufacturer Narrative
Evaluation summary: one sample of endotracheal tube was received for evaluation.A visual inspection was performed and it was observed all the components are assembled properly at the tube.An inflation/deflation test was performed using a syringe, 25cc of air was applied to the cuff and it was noticed the cuff held the air, the cuff was left inflated 2 hours according to process instruction.After this time no deflation was observed, additionally the sample was submerged into a container filled with water and no leaks were observed.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: TAPERGUARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ave henequen no 1181 desarrol,mx 32590 ; MX 32590
• MDR Report Key: 7613422
• Report Number: 2936999-2018-00399
• Device Sequence Number: 19221185
• Product Code: BTR
• UDI-Device Identifier: 30884521032532
• UDI-Public: 30884521032532
• 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): 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 18875
• Device Catalogue Number: 18875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1