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

Model Number	18785S
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2018
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 did not contain stylet.The customer indicated no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.A visual inspection was performed and it was observed the tube is missing the stylet.The failure mode missing component was confirmed in the received sample; consequently a walking process was conducted and was detected that the visual monitor of the weight scale in the device with stylet packaging area was not proper located and makes difficult it's visualization; therefore as a corrective action, the visual monitor was better located in order to improved the monitor visualization which helps to make sure that the correct quantity of pieces was packaged.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; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7809168
• Report Number: 2936999-2018-00531
• Device Sequence Number: 1536560
• 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): 01/28/2019

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: 10/23/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1