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

Model Number	4DIC
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, this inner cannula was in use on a patient and the clinician was unable to advance the suction catheter.The patient was not recannulated and the tube remained in the patient.The reporter stated there was no patient harm.
Additional Manufacturer Narrative
Correction: (name, email).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: upon further review it was determined that this event is not reportable.The report 2936999-2017-05682 is no longer applicable.If information is provided in the future, a supplemental report will be issued.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: 7114895
• Report Number: 2936999-2017-05682
• Device Sequence Number: 16612908
• Product Code: BTO
• UDI-Device Identifier: 50884522005249
• UDI-Public: 50884522005249
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K811447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2018

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: 05/29/2022
• Device Model Number: 4DIC
• Device Catalogue Number: 4DIC
• Device Lot Number: 17E1042JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/26/2018; 02/26/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/19/2018; 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR