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

Model Number	SSVO
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 was a newly opened one and it gave out weird noise when attached to the patient's tracheostomy tube.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for evaluation and no failure was confirmed.A visual inspection was performed and no cuts, deformities or damage was observed in the membrane nor the diaphragm, and the membrane is in the right position.Received sample met with the product specifications and no corrective actions are required.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8192008
• Report Number: 2936999-2018-00789
• Device Sequence Number: 11423279
• Product Code: BTO
• UDI-Device Identifier: 40884522005372
• UDI-Public: 40884522005372
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K945407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: 01/25/2022
• Device Model Number: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 17A0574JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1