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

Model Number 8DIC

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit's inner cannula was blocked and did not allow air to pass.The customer reported that there was no confirmation for the patient outcome.

Manufacturer Narrative

Additional: (udi #).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: one sample was received for evaluation and the reported event was confirmed.A visual inspection was performed, and it was observed the inner diameter of the cannula is occluded with a piece of plastic.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.

Event Description

According to the reporter, when the nurse was performing trach care, upon changing the inner cannula, the vent immediately started alarming and the patient displayed signs of respiratory distress.It was stated that the nurse attempted to suction the patient and could not advance the tubing due to meeting resistance.She got another cannula and swapped it.Once she removed the inner cannula, she inspected it and learned that it was blocked with a piece of plastic.Other than the initial short term respiratory distress, there was no other harm caused to the patient.

Manufacturer Narrative

Correction: (udi #).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 ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7327203
• MDR Text Key: 102084653
• Report Number: 2936999-2018-00151
• Device Sequence Number: 1
• Product Code: BTO
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: 8DIC
• Device Catalogue Number: 8DIC
• Device Lot Number: 17H0318JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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