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

Model Number 137-80

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Date 05/29/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, tracheostomy was performed due to poor ventilation to the critically ill patient connected to mechanical ventilation.Premature dislodgement of the tracheostomy tube was observed after procedure, the tube was removed to be replaced but patient suffered cardiac arrest and died later on.After removing the tube, it was observed that the access to the trachea was not established, the tracheostomy tube was oriented against the right side of the trachea posterior wall, creating a false passage, resulting in loss of the airway.There was no difficulty experienced inserting the device and the tube was placed a few hours.Respirator was connected to the tube while it was in place.

Manufacturer Narrative

Evaluation summary: no sample was returned for evaluation.Review of the two photos shows a unit pack and the remaining photo shows a used unit.Review of the photo shows that the unit is contaminated.Further examination shows that the neck plate and the tubing are not perpendicular.As no sample has been returned it is impossible to confirm if this movement happened as a result of the locking mechanism.Analysis of the retain sample confirms that the lock nut was securely locked to the neck plate and no movement was noted along the main stem of the tubing.Visual examination of the lock nut and the neck plate shows no sign of any moulding issue.The internal diameter of the neck plate and lock nut of the retain sample was measured and found to be within the blueprint specifications.In the absence of the actual complaint sample it is not possible to determine the root cause of this particular issue.All of our flange and lock nuts components are injection moulded, during this moulding process the machine setter and quality controller carry out first piece inspection.During the first piece inspection the quality controller and the machine setter verify the specifications requirements of the locknuts and flange components, measure the components and record their findings.Periodically during the lot run roving inspections are carried out.It is at these stages of the injection moulding process that any issues are identified and removed from the lot.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 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9122721
• MDR Text Key: 160153454
• Report Number: 2936999-2019-00792
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K884730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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 Model Number: 137-80
• Device Catalogue Number: 137-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death; Required Intervention