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

Model Number 6DIC

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

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter,prior to use, the device inner cannula curve on bottom part could not fit into tracheostomy.The customer indicated that there was no patient involvement.

Manufacturer Narrative

Evaluation summary: eighty-seven samples were received for evaluation.The reported event was confirmed on the received samples.A functional test was performed, the samples were tested on the restriction gauge calibration, fifteen cannulas did not presents restriction at the time of insertion nor extraction, and seventy-two cannulas presented a slight restriction at the time of insertion and extraction, all the received inner cannulas were inserted into fixture and according to process instruction, it was observed that the radius was found out of the specification and the distal tips has a deformation.This condition causes difficulty inserting the dic cannula into outer cannula, the deformation condition is present due to the stress created around the gate area during the molding process; this stress is then relieved when the parts are passed through the shrink oven.Additionally, a dimensional test was performed on five of the cannulas that failed on the functional test, these readings are within specification.The molding process was reviewed and it was observed that the deformation condition is present due to the stress created around the gate area during the molding process; as a consequent of use the combination of mold.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 SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 8287796
• MDR Text Key: 134446130
• Report Number: 2936999-2019-00079
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 60884522005284
• UDI-Public: 60884522005284
• Combination Product (y/n): N
• PMA/PMN Number: K811447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Model Number: 6DIC
• Device Catalogue Number: 6DIC
• Device Lot Number: 18F0717JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1