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 Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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 unit did not inflate.There was no patient harm associated with this event.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.The reported event was confirmed.An inflation/deflation test was performed, air was applied to the cuff using a syringe and it was observed inflation was difficult and deflation was hard, it was noticed the air has difficulties to get through the inflation system.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: 8266568
• Report Number: 2936999-2019-00070
• Device Sequence Number: 16676061
• 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,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 05/14/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1