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

Model Number	86445
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2019
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, the unit's tube parts were apart.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation and the reported issue was confirmed.The received sample is missing the connector and this component was not received, a visual inspection was performed and it was observed the proximal end presents marks of insertion of the connector, a dimensional test was performed mark of insertion was measured, the reading is within specification.Inner diameter of the tube was measured this reading is within specification, these readings were taken using vertex calibration and scale number.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: SHILEY
• 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: 9165681
• Report Number: 2936999-2019-00828
• Device Sequence Number: 2811845
• Product Code: BTR
• UDI-Device Identifier: 30884522005719
• UDI-Public: 30884522005719
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 86445
• Device Catalogue Number: 86445
• Device Lot Number: 18F0238JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1