MAUDE Adverse Event Report: MMJ, S.A. DE C.V. SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 10DIC

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during normal procedure, the device had a dimensional issue.It was indicated that while the inner cannula was being introduced inside the tracheostomy tube, they had observed inner cannula resistance.It was stated that the inner cannula and tracheostomy tube were compatible.There was no patient injury.

Manufacturer Narrative

(intervention required).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

One device was received for evaluation.Failure investigator reported: no failure could be found.The investigation found the device to function normally.The reported product was not related to a reported complaint event.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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ, S.A. DE C.V.; ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• Manufacturer (Section G): MMJ, S.A. DE C.V.; ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder,co, MA 80301 ; 3035306582
• MDR Report Key: 7440689
• MDR Text Key: 105901303
• Report Number: 2936999-2018-00271
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 50884522005201
• UDI-Public: 50884522005201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: 10DIC
• Device Catalogue Number: 10DIC
• Device Lot Number: 17E1045JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 09/10/2018
• Supplement Dates FDA Received: 04/19/2018; 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention