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

Model Number	18785S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2019
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, during the pre-test inspection, there was resistance of the pilot balloon when the cuff check was performed.The cuff was difficult to inflate.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of endotracheal tube was received for evaluation.An inflation/deflation test was performed, 25cc of air was applied to the cuff using a syringe and it was observed inflation was difficult and deflation was hard, it was noticed that the air has difficulties to get through the inflation system in the area where the inflation line is inserted into the tube, the failure mode cuff won¿t inflate is confirmed.Corrective actions have been implemented to mitigate this issue.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; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 8411740
• Report Number: 2936999-2019-00181
• Device Sequence Number: 1795982
• Product Code: BTR
• UDI-Device Identifier: 10884521620216
• UDI-Public: 10884521620216
• 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): 06/24/2019

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 Expiration Date: 03/05/2023
• Device Model Number: 18785S
• Device Catalogue Number: 18785S
• Device Lot Number: 18C0155JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1