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

Model Number	18875
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/03/2018
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, the device's cuff was ruptured on the third day of being used and was confirmed having a leakage but could not find the visible hole.The patient was re-cannulated.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The reported event leak at inflation line was confirmed.A visual inspection was performed, and it was observed the inflation line presents cuts.An inflation/deflation test was performed, air was applied to the cuff using a syringe and it was observed the cuff deflated immediately.All manufacturing controls were found acceptable and effective to detect the reported event.Instructions for use (ifu) information such as test the cuff, pilot balloon and valve for integrity by inflation prior to use.Insert a luer tip syringe into the cuff inflation valve housing and inject enough air to fully inflate cuff.After test inflation, completely evacuate the air.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 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8293782
• Report Number: 2936999-2019-00082
• Device Sequence Number: 1587724
• 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): 06/10/2019

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: 18875
• Device Catalogue Number: 18875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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